Magnetic Resonance Imaging, Myocardial Perfusion Imaging
Conditions
Keywords
Cardiac MRI, gadobutrol
Brief summary
The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT examination in terms of diagnostic quality. For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg body weight are administered. A study participant receives the respective dose twice i.e. at rest and at stress using Adenosine (which puts circulation into a state of stress similar to that of physical exercise). The time between both injections is 10-15 min. The total imaging time is about 45 min.
Interventions
DRUGGadobutrol (Gadavist,Gadovist, BAY86-4875)
0.01 mmol/kg BW (0.01 mL/kg) for stress MRI and 0.01 mmol/kg BW (0.01 mL/kg) for rest MRI (total dose 0.02 mmol/kg)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females of any ethnic group with reversible focal hypoperfusion in at least 2 adjoining segments in SPECT * The SPECT examination had been performed within 4 weeks prior to the MRI examination and had been performed for clinical reasons only
Exclusion criteria
* Generalized myocardial hypoperfusion (e.g. severe 3 vessel disease) * Recent myocardial infarction (MI) (within 1 week prior to the study procedure) * Event that significantly altered cardiac performance between SPECT and MRI imaging, e.g. myocardial infarction, unstable angina, alteration of cardiac medication * Non-sinus rhythm * Sinus node disease or symptomatic bradycardia * Second or third degree atrial ventricular (AV) block * Complete left bundle branch block (LBBB) * Known congenital long QT syndrome or a family history of congenital long QT syndrome * Known previous arrhythmias on drugs that prolong cardiac repolarization * Uncorrected hypokalemia * Uncontrolled hypertension (e.g. systolic blood pressure \>185 mm Hg, diastolic blood pressure \>110 mm Hg) * Baseline hypotension (e.g. mean arterial pressure \<60 mm Hg) * Ejection fraction below 35% * Cardiomyopathy, congenital heart defect or higher degree valvular pathology * Coronary artery stent placement within 4 weeks prior to the MRI procedure * Previous heart transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion Magnetic Resonance (MR) images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (left anterior decendent \[LAD\], left circumflex \[LCX\], right coronary artery \[RCA\]). Data were compared to the corresponding regional data from Single Photon Emission Computer Tomography (SPECT). The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and number of the myocardial regions. |
| Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as scar in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of 'scar'. The number of regional assessments is defined as the number of regions with diagnosis 'scar' assessed by at least 1 blinded reader. |
| Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as scar in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of scar. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by at least 1 blinded reader. |
| Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as scar in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of scar. The number of regional assessments is defined as the number of segments with diagnosis scar assessed by the investigator. |
| Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as scar in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental SPECT diagnosis of scar. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by the investigator. |
| Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as ischemia in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of ischemia.The number of regional assessments is defined as the number of regions with diagnosis ischemia assessed by at least 1 blinded reader. |
| Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as ischemia in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of ischemia. The number of segmental assessments is defined as the number of segments with diagnosis ischemia assessed by at least 1 blinded reader. |
| Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as ischemia in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of ischemia. The number of regional assessments is defined as the number of regions with diagnosis ischemia assessed by the investigator. |
| Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as ischemia in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of ischemia. The number of segmental assessments is defined as the number of segments with diagnosis ischemia assessed by the investigator. |
| Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions. |
| Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments. |
| Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions. |
| Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association).MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments. |
| Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both, in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions. |
| Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data derived from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments. |
| Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress MR images were evaluated by 3 independent blinded readers regarding the presence/absence of artifacts in 16 myocardial segments (according to the American Heart Association). The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments. |
| Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress MR images were evaluated by the investigator regarding the presence/absence of artifacts in 16 myocardial segments (defined according to the American Heart Association). The number of segments with artifacts was calculated by multiplication of the number of participants with the number of the myocardial segments. |
| Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of \> 70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions. |
| Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions) | Immediately within approximately 5 seconds after Gadobutrol bolus administration | MPRI was calculated for the upslope of the signal intensity /time curve on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). The upslope-value at post-stress was divided by the value at rest. MPRI \<=1.5 (perfusion defect) and \>1.5 (normal) were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of \>70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions. |
| Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | For patients undergoing coronary angiography additionally to SPECT, a Truth Panel with 2 cardiology experts was employed as SoT to come to a consensus diagnosis. Rest and stress MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion defects in 3 myocardial regions representing the 3 arterial territories/arteries of the heart. These data were compared to the SoT diagnosis. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions. |
| Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MPRIs \<= 1.5 (perfusion defect) and \>1.5 (normal) were compared to presence/absence of perfusion defects in the regional data analysis from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions. |
| Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 16 myocardial segments (defined according to the American Heart Association). MPRIs \<= 1.5 (perfusion defect) and \>1.5 (normal) were then compared to presence/absence of perfusion defects in the segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments. |
| Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA): Visual and semiquantitative data were compared to each other per region. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions. |
| Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 16 myocardial segments (defined according to the American Heart Association). Visual and semiquantitative data were compared to each other per segment. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments. |
| Signal Intensity (SIrel) Based on Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | The signal intensity (SIrel) is determined over time. SI (SIrel) is the upslope in myocardium divided by upslope of the ventricle, as assessed for normal and underperfused segments. SI(rel) = upslope myocard / upslope ventricle. MR segments were evaluated for signal intensity (SIrel) in order to assess if a difference between normal and diseased (i.e. ischemia/scar/mixed) segments could be demonstrated (normal/diseased was defined by central reading of SPECT). |
| Upslope Based on Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Upslope is defined as the maximum slope of the signal intensity (SI) increase on the SI/time curve (determined by a linear fit) during 3 consecutive heart beats reported in Units/sec. The upslope was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT). |
| Time to Peak Based on Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration up to 2 minutes | Time to peak is defined as the time in seconds from start to maximum signal intensity (SI max) on the SI curve and was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT). |
| Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration | Delayed enhancement (DE) -\[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions\]- MR images acquired at different time points, were evaluated by 3 independent blinded readers for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 arterial territories of the heart. DE data were compared to the diagnosis scar derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis scar assessed by at least 1 blinded reader. |
| Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration | Delayed enhancement -\[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions\]- MR images acquired at different time points were evaluated by 3 independent blinded readers regarding the presence/absence of DE at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis scar derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by at least 1 blinded reader. |
| Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration | Delayed enhancement (DE) -\[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions\]- MR images acquired at different time points, were evaluated by the clinical investigator for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). DE data were compared to the diagnosis scar derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis scar assessed by the investigator. |
| Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration | Delayed enhancement (DE)-\[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions\]- MR images acquired at different time points were evaluated by the respective investigator regarding the presence/absence of delayed enhancement at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis scar derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by the investigator. |
| Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Results are displayed on a per patient basis. |
| Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. |
| Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized |
| Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. |
| Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized. |
| Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. |
| Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized. |
| Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. |
| Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized. |
| Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. |
| Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized. |
| Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. |
| Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized. |
| Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. |
| Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized. |
| Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. |
| Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). |
| Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions. |
| Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA). |
| Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). |
| Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. |
| Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. |
| Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) | Immediately within approximately 5 seconds after Gadobutrol bolus administration | — |
| Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA). |
| Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Immediately within approximately 5 seconds after Gadobutrol bolus administration | Rest and stress perfusion MR images were evaluated by the respective investigator for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments. |
Countries
Austria, Germany, Poland, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. | 54 |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. | 60 |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. | 58 |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. | 54 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 |
| Overall Study | Prematurely discontinuation | 4 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 62.0 Years | 61.5 Years | 64.5 Years | 61.0 Years | 62.0 Years |
| History of myocardial infarction No | 34 Participants | 42 Participants | 43 Participants | 37 Participants | 156 Participants |
| History of myocardial infarction Unknown | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| History of myocardial infarction Yes | 20 Participants | 17 Participants | 15 Participants | 15 Participants | 67 Participants |
| Sex: Female, Male Female | 15 Participants | 19 Participants | 17 Participants | 19 Participants | 70 Participants |
| Sex: Female, Male Male | 39 Participants | 41 Participants | 41 Participants | 35 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 54 | 1 / 60 | 4 / 58 | 5 / 54 |
| serious Total, serious adverse events | 0 / 54 | 0 / 60 | 0 / 58 | 0 / 54 |
Outcome results
Primary
Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions
Rest and stress perfusion Magnetic Resonance (MR) images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (left anterior decendent \[LAD\], left circumflex \[LCX\], right coronary artery \[RCA\]). Data were compared to the corresponding regional data from Single Photon Emission Computer Tomography (SPECT). The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and number of the myocardial regions.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: Per protocol set (PPS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Disagreement | 58.8 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Agreement | 41.2 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Agreement | 55.9 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Disagreement | 44.1 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Disagreement | 36.7 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Agreement | 63.3 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Disagreement | 40.3 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Agreement | 59.7 Percent regional assessments |
Primary
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments
Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: Per protocol set (PPS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Disagreement | 51.1 Percent segmental assessment |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Agreement | 48.9 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Agreement | 60.6 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Disagreement | 39.4 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Disagreement | 34.5 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Agreement | 65.5 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Disagreement | 34.1 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Agreement | 65.9 Percent segmental assessment |
Secondary
Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.
Time frame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 1 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Poor | 1 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 3 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Poor | 5 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 5 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 4 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Poor | 3 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 12 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 2 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 2 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Poor | 3 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 12 Participants |
Secondary
Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.
Time frame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 4 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 0 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 0 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 13 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 2 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 5 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 5 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 13 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 22 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 15 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 21 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 15 Delayed enhancement assessments |
Secondary
Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.
Time frame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Poor | 4 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 0 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 0 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Poor | 11 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 2 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 2 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 11 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Poor | 13 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 20 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Poor | 15 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 25 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 16 Delayed enhancement assessments |
Secondary
Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.
Time frame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Poor | 3 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 1 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 1 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Poor | 4 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 5 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 3 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 10 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Poor | 3 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 4 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 12 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 1 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Poor | 4 Participants |
Secondary
Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.
Time frame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 0 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 0 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Poor | 5 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 4 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Poor | 12 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 3 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Poor | 12 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 18 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 14 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 25 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 21 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) | Poor | 14 Delayed enhancement assessments |
Secondary
Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.
Time frame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Poor | 4 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 0 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 1 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Poor | 2 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 4 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 5 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 3 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Poor | 2 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 10 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Poor | 3 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 12 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 1 Participants |
Secondary
Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.
Time frame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 0 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 5 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 0 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 11 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 2 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 1 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 13 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 24 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 3 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 20 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 8 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 21 Delayed enhancement assessments |
Secondary
Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.
Time frame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 2 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 0 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 0 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 3 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 2 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 5 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 3 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 3 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 7 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 4 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 11 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 1 Participants |
Secondary
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized
Time frame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 3 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 0 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 0 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 11 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 4 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 5 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 3 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 14 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 23 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 14 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 25 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 12 Delayed enhancement assessments |
Secondary
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.
Time frame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 1 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 2 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 2 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 6 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 5 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 3 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 3 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 2 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 12 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 3 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 12 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 2 Participants |
Secondary
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.
Time frame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 3 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 0 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 0 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 8 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 3 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 4 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 6 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 15 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 23 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 17 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 28 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 11 Delayed enhancement assessments |
Secondary
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.
Time frame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 2 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 1 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 2 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 5 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 3 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 4 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 6 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 2 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 9 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 4 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 12 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 1 Participants |
Secondary
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.
Time frame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 5 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 0 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 0 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 11 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 4 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 4 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 10 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 15 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 19 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Poor | 18 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 25 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 17 Delayed enhancement assessments |
Secondary
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.
Time frame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 4 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 0 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 1 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 3 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 3 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 5 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 5 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 1 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 9 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 3 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 13 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 0 Participants |
Secondary
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Results are displayed on a per patient basis.
Time frame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. The evaluation included only participants with delayed enhancement in at least 1 segment ( PPS) based on the assessment of at least one blinded reader.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | Poor | 5 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | good/excellent | 0 Delayed enhancement assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | Satisfactory | 0 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | Poor | 12 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | good/excellent | 1 Delayed enhancement assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | Satisfactory | 1 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | Satisfactory | 6 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | Poor | 11 Delayed enhancement assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | good/excellent | 23 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | Poor | 8 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | good/excellent | 26 Delayed enhancement assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) | Satisfactory | 15 Delayed enhancement assessments |
Secondary
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.
Time frame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 1 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 1 Participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 0 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 4 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 2 Participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 4 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 4 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 1 Participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 8 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Poor | 4 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Good/excellent | 10 Participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) | Satisfactory | 2 Participants |
Secondary
Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions
Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as ischemia in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of ischemia.The number of regional assessments is defined as the number of regions with diagnosis ischemia assessed by at least 1 blinded reader.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 region in SPECT were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Disagreement | 87.9 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Agreement | 12.1 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Agreement | 30.7 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Disagreement | 69.3 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Disagreement | 64.4 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Agreement | 35.6 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Disagreement | 60.6 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Agreement | 39.4 Percent regional assessments |
Secondary
Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments
Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as ischemia in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of ischemia. The number of segmental assessments is defined as the number of segments with diagnosis ischemia assessed by at least 1 blinded reader.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 segment in SPECT were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Disagreement | 91.8 Percent segmental assessment |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Agreement | 8.2 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Agreement | 22.5 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Disagreement | 77.5 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Disagreement | 74.3 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Agreement | 25.7 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Disagreement | 68.9 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Agreement | 31.1 Percent segmental assessment |
Secondary
Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions
Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as ischemia in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of ischemia. The number of regional assessments is defined as the number of regions with diagnosis ischemia assessed by the investigator.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 region in SPECT were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Disagreement | 63.5 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Agreement | 36.5 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Agreement | 38.5 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Disagreement | 61.5 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Disagreement | 48.3 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Agreement | 51.7 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Disagreement | 46.7 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions | Agreement | 53.3 Percent regional assessments |
Secondary
Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments
Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as ischemia in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of ischemia. The number of segmental assessments is defined as the number of segments with diagnosis ischemia assessed by the investigator.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 segment in SPECT were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Disagreement | 77.4 Percent segmental assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Agreement | 22.6 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Agreement | 33.3 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Disagreement | 66.7 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Disagreement | 58.4 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Agreement | 41.6 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Disagreement | 58.2 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments | Agreement | 41.8 Percent segmental assessments |
Secondary
Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions
Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as scar in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of 'scar'. The number of regional assessments is defined as the number of regions with diagnosis 'scar' assessed by at least 1 blinded reader.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 region in SPECT were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Disagreement | 81.3 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Agreement | 18.8 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Agreement | 19.4 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Disagreement | 80.6 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Disagreement | 83.3 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Agreement | 16.7 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Disagreement | 86.5 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Agreement | 13.5 Percent regional assessments |
Secondary
Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments
Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as scar in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of scar. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by at least 1 blinded reader.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 segment in SPECT were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Disagreement | 88.4 Percent segmental assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Agreement | 11.6 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Agreement | 14.3 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Disagreement | 85.7 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Disagreement | 82.0 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Agreement | 18.0 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Disagreement | 90.8 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Agreement | 9.2 Percent segmental assessments |
Secondary
Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions
Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as scar in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of scar. The number of regional assessments is defined as the number of segments with diagnosis scar assessed by the investigator.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 region in SPECT were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Disagreement | 81.8 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Agreement | 18.2 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Agreement | 24.0 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Disagreement | 76.0 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Disagreement | 76.5 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Agreement | 23.5 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Disagreement | 85.7 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions | Agreement | 14.3 Percent regional assessments |
Secondary
Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments
Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as scar in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental SPECT diagnosis of scar. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by the investigator.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 segment in SPECT were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Disagreement | 86.4 Percent segmental assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Agreement | 13.6 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Agreement | 15.2 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Disagreement | 84.8 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Disagreement | 69.7 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Agreement | 30.3 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Disagreement | 88.0 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments | Agreement | 12.0 Percent segmental assessments |
Secondary
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions
Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions | Disagreement | 67.4 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions | Agreement | 32.6 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions | Agreement | 42.7 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions | Disagreement | 57.3 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions | Disagreement | 46.8 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions | Agreement | 53.2 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions | Disagreement | 53.0 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions | Agreement | 47.0 Percent regional assessments |
Secondary
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments
Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Disagreement | 53.8 Percent segmental assessment |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Agreement | 46.2 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Agreement | 57.3 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Disagreement | 42.7 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Disagreement | 36.8 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Agreement | 63.2 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Disagreement | 37.3 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Agreement | 62.7 Percent segmental assessment |
Secondary
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions
For patients undergoing coronary angiography additionally to SPECT, a Truth Panel with 2 cardiology experts was employed as SoT to come to a consensus diagnosis. Rest and stress MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion defects in 3 myocardial regions representing the 3 arterial territories/arteries of the heart. These data were compared to the SoT diagnosis. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions | Disagreement | 62.8 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions | Agreement | 37.2 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions | Agreement | 48.6 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions | Disagreement | 51.4 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions | Disagreement | 53.6 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions | Agreement | 46.4 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions | Disagreement | 40.7 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions | Agreement | 59.3 Percent regional assessments |
Secondary
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses
Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of \> 70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses | Disagreement | 50.6 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses | Agreement | 49.4 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses | Agreement | 51.9 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses | Disagreement | 48.1 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses | Disagreement | 38.8 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses | Agreement | 61.2 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses | Disagreement | 32.3 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses | Agreement | 67.7 Percent regional assessments |
Secondary
Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions
Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions | Disagreement | 52.3 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions | Agreement | 47.7 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions | Agreement | 50.9 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions | Disagreement | 49.1 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions | Disagreement | 42.1 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions | Agreement | 57.9 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions | Disagreement | 46.5 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions | Agreement | 53.5 Percent regional assessments |
Secondary
Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments
Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association).MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Disagreement | 40.9 Percent segmental assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Agreement | 59.1 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Agreement | 67.0 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Disagreement | 33.0 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Disagreement | 31.1 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Agreement | 68.9 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Disagreement | 35.6 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments | Agreement | 64.4 Percent segmental assessments |
Secondary
Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions
Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Disagreement | 48.5 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Agreement | 51.5 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Agreement | 60.8 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Disagreement | 39.2 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Disagreement | 35.2 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Agreement | 64.8 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Disagreement | 37.7 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions | Agreement | 62.3 Percent regional assessments |
Secondary
Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments
Rest and stress perfusion MR images were evaluated by the respective investigator for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Disagreement | 39.3 Percent segmental assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Agreement | 60.7 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Agreement | 69.6 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Disagreement | 30.4 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Disagreement | 28.7 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Agreement | 71.3 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Disagreement | 33.3 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments | Agreement | 66.7 Percent segmental assessments |
Secondary
Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA).
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments | 7.3 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments | 27.1 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments | 23.8 Percent segmental assessment |
Secondary
Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA).
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions | 20.0 Percent regional assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions | 72.7 Percent regional assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions | 87.5 Percent regional assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions | 92.9 Percent regional assessment |
Secondary
Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA).
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments | 41.7 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments | 75.0 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments | 82.4 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments | 100.0 Percent segmental assessment |
Secondary
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions
Delayed enhancement (DE) -\[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions\]- MR images acquired at different time points, were evaluated by 3 independent blinded readers for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 arterial territories of the heart. DE data were compared to the diagnosis scar derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis scar assessed by at least 1 blinded reader.
Time frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 5 min DE | 0.0 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 10 min DE | 0.0 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 15 min DE | 0.0 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 20 min DE | 0.0 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 10 min DE | 5.6 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 15 min DE | 2.8 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 20 min DE | 2.8 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 5 min DE | 1.4 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 15 min DE | 19.0 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 10 min DE | 19.0 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 20 min DE | 19.0 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 5 min DE | 14.3 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 20 min DE | 39.6 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 10 min DE | 33.3 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 5 min DE | 36.5 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 15 min DE | 38.5 Percent regional assessments |
Secondary
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments
Delayed enhancement -\[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions\]- MR images acquired at different time points were evaluated by 3 independent blinded readers regarding the presence/absence of DE at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis scar derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by at least 1 blinded reader.
Time frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 5 min DE | 0.0 Percent segmental assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 10 min DE | 0.0 Percent segmental assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 15 min DE | 0.0 Percent segmental assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 20 min DE | 0.0 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 10 min DE | 2.7 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 15 min DE | 1.4 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 20 min DE | 1.4 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 5 min DE | 0.7 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 15 min DE | 20.7 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 10 min DE | 20.7 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 20 min DE | 20.7 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 5 min DE | 18.9 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 20 min DE | 36.4 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 10 min DE | 28.7 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 5 min DE | 31.3 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 15 min DE | 35.4 Percent segmental assessments |
Secondary
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions
Delayed enhancement (DE) -\[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions\]- MR images acquired at different time points, were evaluated by the clinical investigator for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). DE data were compared to the diagnosis scar derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis scar assessed by the investigator.
Time frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 region in SPECT were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 5 min DE | 6.3 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 10 min DE | 6.3 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 15 min DE | 6.3 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 20 min DE | 6.3 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 10 min DE | 4.2 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 15 min DE | 12.5 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 20 min DE | 4.2 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 5 min DE | 4.2 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 15 min DE | 28.6 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 10 min DE | 28.6 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 20 min DE | 21.4 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 5 min DE | 21.4 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 20 min DE | 37.5 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 10 min DE | 37.5 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 5 min DE | 25.0 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions | region - 15 min DE | 37.5 Percent regional assessments |
Secondary
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments
Delayed enhancement (DE)-\[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions\]- MR images acquired at different time points were evaluated by the respective investigator regarding the presence/absence of delayed enhancement at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis scar derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by the investigator.
Time frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 5 min DE | 4.7 Percent segmental assessment |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 10 min DE | 7.0 Percent segmental assessment |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 15 min DE | 9.3 Percent segmental assessment |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 20 min DE | 2.3 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 10 min DE | 2.0 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 15 min DE | 6.1 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 20 min DE | 2.0 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 5 min DE | 2.0 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 15 min DE | 18.9 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 10 min DE | 24.3 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 20 min DE | 18.9 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 5 min DE | 21.6 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 20 min DE | 30.8 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 10 min DE | 30.8 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 5 min DE | 23.1 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments | segment - 15 min DE | 32.3 Percent segmental assessment |
Secondary
Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions)
MPRI was calculated for the upslope of the signal intensity /time curve on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). The upslope-value at post-stress was divided by the value at rest. MPRI \<=1.5 (perfusion defect) and \>1.5 (normal) were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of \>70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions) | Disagreement | 53.7 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions) | Agreement | 46.3 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions) | Agreement | 59.3 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions) | Disagreement | 40.7 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions) | Disagreement | 60.3 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions) | Agreement | 39.7 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions) | Disagreement | 56.7 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions) | Agreement | 43.3 Percent regional assessments |
Secondary
Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions
MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MPRIs \<= 1.5 (perfusion defect) and \>1.5 (normal) were compared to presence/absence of perfusion defects in the regional data analysis from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions | Disagreement | 62.1 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions | Agreement | 37.9 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions | Agreement | 39.2 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions | Disagreement | 60.8 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions | Disagreement | 59.1 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions | Agreement | 40.9 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions | Disagreement | 66.0 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions | Agreement | 34.0 Percent regional assessments |
Secondary
Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments
MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 16 myocardial segments (defined according to the American Heart Association). MPRIs \<= 1.5 (perfusion defect) and \>1.5 (normal) were then compared to presence/absence of perfusion defects in the segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments | Disagreement | 69.6 Percent segmental assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments | Agreement | 30.4 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments | Agreement | 43.0 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments | Disagreement | 57.0 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments | Disagreement | 48.9 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments | Agreement | 51.1 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments | Disagreement | 49.4 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments | Agreement | 50.6 Percent segmental assessments |
Secondary
Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments
Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 16 myocardial segments (defined according to the American Heart Association). Visual and semiquantitative data were compared to each other per segment. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments | Disagreement | 53.0 Percent segmental assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments | Agreement | 47.0 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments | Agreement | 53.7 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments | Disagreement | 46.3 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments | Disagreement | 41.8 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments | Agreement | 58.2 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments | Disagreement | 43.7 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments | Agreement | 56.3 Percent segmental assessments |
Secondary
Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions
Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA): Visual and semiquantitative data were compared to each other per region. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions | Disagreement | 56.3 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions | Agreement | 43.7 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions | Agreement | 44.8 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions | Disagreement | 55.2 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions | Disagreement | 49.1 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions | Agreement | 50.9 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions | Disagreement | 58.3 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions | Agreement | 41.7 Percent regional assessments |
Secondary
Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments
Rest and stress MR images were evaluated by 3 independent blinded readers regarding the presence/absence of artifacts in 16 myocardial segments (according to the American Heart Association). The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | Missing | 1.8 Percentage of segments with artifacts |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | No | 66.3 Percentage of segments with artifacts |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | Yes | 31.9 Percentage of segments with artifacts |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | Yes | 35.9 Percentage of segments with artifacts |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | No | 62.7 Percentage of segments with artifacts |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | Missing | 1.4 Percentage of segments with artifacts |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | Missing | 2.8 Percentage of segments with artifacts |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | No | 62.1 Percentage of segments with artifacts |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | Yes | 35.0 Percentage of segments with artifacts |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | Yes | 32.2 Percentage of segments with artifacts |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | No | 66.3 Percentage of segments with artifacts |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments | Missing | 1.5 Percentage of segments with artifacts |
Secondary
Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments
Rest and stress MR images were evaluated by the investigator regarding the presence/absence of artifacts in 16 myocardial segments (defined according to the American Heart Association). The number of segments with artifacts was calculated by multiplication of the number of participants with the number of the myocardial segments.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | No | 85.5 Percentage of segments with artifacts |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Yes | 14.5 Percentage of segments with artifacts |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Not assessable | 0.0 Percentage of segments with artifacts |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Not determined | 0.0 Percentage of segments with artifacts |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Yes | 14.7 Percentage of segments with artifacts |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Not assessable | 0.0 Percentage of segments with artifacts |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Not determined | 0.0 Percentage of segments with artifacts |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | No | 85.3 Percentage of segments with artifacts |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Not assessable | 1.4 Percentage of segments with artifacts |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Yes | 17.1 Percentage of segments with artifacts |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Not determined | 0.0 Percentage of segments with artifacts |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | No | 81.5 Percentage of segments with artifacts |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Not determined | 0.7 Percentage of segments with artifacts |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Yes | 15.8 Percentage of segments with artifacts |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | No | 83.5 Percentage of segments with artifacts |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments | Not assessable | 0.0 Percentage of segments with artifacts |
Secondary
Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation)
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in FAS with assessment for this outcome measure. Evaluation included all participants in the full analysis population with an assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) | Yes | 13.5 Percentage of participants |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) | No | 86.5 Percentage of participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) | Yes | 23.3 Percentage of participants |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) | No | 76.7 Percentage of participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) | No | 76.8 Percentage of participants |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) | Yes | 23.2 Percentage of participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) | Yes | 14.8 Percentage of participants |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) | No | 85.2 Percentage of participants |
Secondary
Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.
Time frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration
Population: PPS. Evaluation included all participants in the per protocol population with an assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 5 min DE | 23.9 Percent segmental assessment |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 10 min DE | 25.3 Percent segmental assessment |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 15 min DE | 20.9 Percent segmental assessment |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 20 min DE | 19.2 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 10 min DE | 19.4 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 15 min DE | 18.0 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 20 min DE | 16.4 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 5 min DE | 22.3 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 15 min DE | 20.7 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 10 min DE | 18.2 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 20 min DE | 18.7 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 5 min DE | 26.7 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 20 min DE | 21.8 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 10 min DE | 22.6 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 5 min DE | 26.2 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) | 15 min DE | 24.7 Percent segmental assessment |
Secondary
Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation)
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.
Time frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 20 min DE | 24.9 Percent segmental assessment |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 5 min DE | 26.8 Percent segmental assessment |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 10 min DE | 23.3 Percent segmental assessment |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 15 min DE | 23.7 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 5 min DE | 24.9 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 10 min DE | 21.3 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 15 min DE | 19.4 Percent segmental assessment |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 20 min DE | 22.8 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 20 min DE | 13.4 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 5 min DE | 21.3 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 15 min DE | 13.7 Percent segmental assessment |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 10 min DE | 10.6 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 15 min DE | 11.9 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 20 min DE | 14.2 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 10 min DE | 13.8 Percent segmental assessment |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) | 5 min DE | 11.7 Percent segmental assessment |
Secondary
Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions
Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both, in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions | Disagreement | 66.2 Percent regional assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions | Agreement | 33.8 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions | Agreement | 46.2 Percent regional assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions | Disagreement | 53.8 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions | Disagreement | 51.4 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions | Agreement | 48.6 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions | Disagreement | 53.5 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions | Agreement | 46.5 Percent regional assessments |
Secondary
Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments
Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data derived from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments | Disagreement | 48.5 Percent segmental assessments |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments | Agreement | 51.5 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments | Agreement | 58.8 Percent segmental assessments |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments | Disagreement | 41.2 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments | Disagreement | 35.6 Percent segmental assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments | Agreement | 64.4 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments | Disagreement | 35.3 Percent segmental assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments | Agreement | 64.7 Percent segmental assessments |
Secondary
Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions
Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA).
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions | 12.1 Percent regional assessments |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions | 21.2 Percent regional assessments |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions | 27.5 Percent regional assessments |
Secondary
Signal Intensity (SIrel) Based on Segments
The signal intensity (SIrel) is determined over time. SI (SIrel) is the upslope in myocardium divided by upslope of the ventricle, as assessed for normal and underperfused segments. SI(rel) = upslope myocard / upslope ventricle. MR segments were evaluated for signal intensity (SIrel) in order to assess if a difference between normal and diseased (i.e. ischemia/scar/mixed) segments could be demonstrated (normal/diseased was defined by central reading of SPECT).
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Signal Intensity (SIrel) Based on Segments | Normal segment | 0.768 Signal intensity | Standard Deviation 2.0791 |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Signal Intensity (SIrel) Based on Segments | Disease segment | 0.732 Signal intensity | Standard Deviation 1.5511 |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Signal Intensity (SIrel) Based on Segments | Disease segment | 0.603 Signal intensity | Standard Deviation 0.5428 |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Signal Intensity (SIrel) Based on Segments | Normal segment | 0.625 Signal intensity | Standard Deviation 0.3992 |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Signal Intensity (SIrel) Based on Segments | Normal segment | 0.708 Signal intensity | Standard Deviation 0.8233 |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Signal Intensity (SIrel) Based on Segments | Disease segment | 0.813 Signal intensity | Standard Deviation 2.0755 |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Signal Intensity (SIrel) Based on Segments | Normal segment | 0.615 Signal intensity | Standard Deviation 0.2428 |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Signal Intensity (SIrel) Based on Segments | Disease segment | 0.584 Signal intensity | Standard Deviation 0.2424 |
Secondary
Time to Peak Based on Segments
Time to peak is defined as the time in seconds from start to maximum signal intensity (SI max) on the SI curve and was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT).
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration up to 2 minutes
Population: PPS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Time to Peak Based on Segments | Normal segment | 12.43 Seconds | Standard Deviation 4.241 |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Time to Peak Based on Segments | Disease segment | 12.11 Seconds | Standard Deviation 3.796 |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Time to Peak Based on Segments | Disease segment | 13.67 Seconds | Standard Deviation 4.104 |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Time to Peak Based on Segments | Normal segment | 13.83 Seconds | Standard Deviation 4.407 |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Time to Peak Based on Segments | Normal segment | 13.87 Seconds | Standard Deviation 4.636 |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Time to Peak Based on Segments | Disease segment | 15.75 Seconds | Standard Deviation 4.982 |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Time to Peak Based on Segments | Normal segment | 15.34 Seconds | Standard Deviation 4.403 |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Time to Peak Based on Segments | Disease segment | 16.34 Seconds | Standard Deviation 4.519 |
Secondary
Upslope Based on Segments
Upslope is defined as the maximum slope of the signal intensity (SI) increase on the SI/time curve (determined by a linear fit) during 3 consecutive heart beats reported in Units/sec. The upslope was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT).
Time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Population: PPS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Upslope Based on Segments | Normal segment | 11.44 Units/sec | Standard Deviation 7.389 |
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Upslope Based on Segments | Disease segment | 11.41 Units/sec | Standard Deviation 6.73 |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Upslope Based on Segments | Disease segment | 17.90 Units/sec | Standard Deviation 8.587 |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Upslope Based on Segments | Normal segment | 18.18 Units/sec | Standard Deviation 9.85 |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Upslope Based on Segments | Normal segment | 27.49 Units/sec | Standard Deviation 17.704 |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Upslope Based on Segments | Disease segment | 22.13 Units/sec | Standard Deviation 13.997 |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Upslope Based on Segments | Disease segment | 26.93 Units/sec | Standard Deviation 19.89 |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Upslope Based on Segments | Normal segment | 31.31 Units/sec | Standard Deviation 24.339 |