Coronary Artery Disease
Conditions
Keywords
Myocardial Perfusion Imaging
Brief summary
Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion (specificity) of coronary artery disease utilizing a uniform image acquisition software. The CMR images will be tested either against the results from routine clinical Coronary Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment or be scheduled up to 4/6 weeks after the study. CMRI and CA/CTA images will be collected for an independent image review (blinded read).
Interventions
DRUGGadobutrol (Gadovist, Gadavist, BAY86-4875)
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female participants aged ≥18 years * Participants with suspected or known CAD based on signs and/or (typical or atypical) chest pain who have routine CA without intervention or CTA within 4 weeks around gadobutrol-enhanced CMRI * Willingness to undergo stress/rest CMRI and to follow directions and complete all study procedures * Women of childbearing potential (e.g. age \< 60y, no history of surgical sterilization or hysterectomy): use of contraception and a negative pregnancy test
Exclusion criteria
* Suspected clinical instability or unpredictability of the clinical course during the study period * Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severe claustrophobia, metallic devices such as pace makers) * History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents according to the investigator's assessment / judgment * Estimated glomerular filtration rate (eGFR) value \<30 mL/min/1.73 m\^2 derived from a serum / blood creatinine result within 2 weeks prior to gadobutrol injection. Any participant on hemodialysis or peritoneal dialysis is excluded from enrollment. * Acute renal insufficiency * Coronary artery bypass grafting (CABG) * Acute myocardial infarction (\< 14 days prior to inclusion), unstable angina / acute coronary syndrome, severe congestive heart failure * Irregular heart rhythm * Condition that precludes the safe administration of pharmacological stressor according to the respective approved label such as sinus node disease, 2nd or 3rd degree atrioventricular block, obstructive lung disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment | 0 to 30/40 minute (min) post-injection | Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative). |
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Sensitivity Based on the Blinded Readers' Assessment | 0 to 30/40 min post-injection | Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=70% for secondary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis. |
| Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Specificity Based on the Blinded Readers' Assessment | 0 to 30/40 min post-injection | Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Specificity= true negative/ (true negative + false positive). |
| Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Specificity Based on the Blinded Readers' Assessment | 0 to 30/40 min post-injection | Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=70% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was prospective analysis. |
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | 0 to 30/40 min post-injection | Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative). |
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | 0 to 30/40 min post-injection | Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=70% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | 0 to 30/40 min post-injection | Sensitivity was calculated coronary territory based, a coronary territory (left anterior descending artery \[LAD\] / non-LAD / right coronary artery \[RCA\] / left circumflex artery \[LCX\]) was rated positive for significant CAD (significant CAD defined as QCA stenosis of\>=50%), if \>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \>=1. A coronary territory(LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator. |
| Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | 0 to 30/40 min post-injection | Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=70%), if \>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of sensitivity was prospective analysis. |
| Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | 0 to 30/40 min post-injection | Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=50%), if \>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator. |
| Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | 0 to 30/40 min post-injection | Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=70%), if \>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of specificity was prospective analysis. |
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Investigator's Assessment | 0 to 30/40 min post-injection | Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (significant CAD defined as QCA stenosis of \>=50%). Sensitivity= true positive/ (true positive + false negative). |
| Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | 0 to 30/40 min post-injection | Sensitivity was calculated for detection of myocardial perfusion defects (MPD) on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If \>=1 myocardial region showed a myocardial perfusion defect with a RPS of \>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=50%). Sensitivity= true positive/ (true positive + false negative). |
| Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | 0 to 30/40 min post-injection | Sensitivity was calculated for detection of MPD on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If \>=1 myocardial region showed a myocardial perfusion defect with a RPS of \>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis. |
| Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | 0 to 30/40 min post-injection | Score for confidence in diagnosis (not confident, somewhat confident, and confident) was described descriptively for each of the 6 myocardial regions. The frequency over the worst confidence in diagnosis obtained within a participant was displayed. All these analyses were done separately for gadobutrol-enhanced CMRI and unenhanced wall motion CMRI. |
| Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | 0 to 30/40 min post-injection | Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI in participants with significant left main stem (LMS) stenosis and the myocardial perfusion defect pattern was described. If \>=1 myocardial region showed a myocardial perfusion defect with a RPS of \>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=50%). Sensitivity= true positive/ (true positive + false negative). |
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment | 0 to 30/40 min post-injection | Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (significant CAD defined as QCA stenosis of \>=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis. |
| Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Investigator's Assessment | 0 to 30/40 min post-injection | Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of \>=50% by QCA, which were secondary analysis. Specificity= true negative/ (true negative + false positive). |
| Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Investigator's Assessment | 0 to 30/40 min post-injection | Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of \>=70% by QCA, which were secondary analysis. Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was prospective analysis. |
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment | 0 to 30/40 min post-injection | Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based sensitivity and specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of \>=50% by QCA, which were secondary analysis. Sensitivity= true positive/ (true positive + false negative). |
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment | 0 to 30/40 min post-injection | Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based sensitivity and specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of \>=70% by QCA, which were secondary analysis. Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis. |
Countries
France, Germany, New Zealand, South Korea, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 23 study centers in 7 countries (Germany, South Korea, United Kingdom, France, United States, New Zealand and Switzerland), between 19 July 2013 (first subject first visit) and 10 April 2015 (last subject last visit).
Pre-assignment details
Overall, 456 participants signed the informed consent, of them 19 did not finish their baseline visit (6 screening failure, 13 dropped out), 1 discontinued the study due to an adverse event (AE). A total of 436 participants entered the diagnostic imaging phase, of them 426 were treated with gadobutrol and entered the follow-up phase.
Participants by arm
| Arm | Count |
|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. | 426 |
| Total | 426 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Other reason | 10 |
Baseline characteristics
| Characteristic | Gadobutrol 0.1 mmol/kg Body Weight |
|---|---|
| Age Categorical >= 45 to <= 64 years | 232 Count of Participants |
| Age Categorical < 45 years | 60 Count of Participants |
| Age Categorical >= 65 years | 134 Count of Participants |
| Age, Continuous | 58.4 Years STANDARD_DEVIATION 11.9 |
| Body Mass Index | 27.160 Kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.561 |
| Body Weight | 79.75 Kilogram (kg) STANDARD_DEVIATION 16.29 |
| Childbearing Potential No childbearing potential (only females) | 109 Count of Participants |
| Childbearing Potential No childbearing potential (only males) | 297 Count of Participants |
| Childbearing Potential Of childbearing potential (only females) | 20 Count of Participants |
| Country France | 4 Participants |
| Country Germany | 210 Participants |
| Country New Zealand | 1 Participants |
| Country South Korea | 108 Participants |
| Country Switzerland | 44 Participants |
| Country United Kingdom | 28 Participants |
| Country United States of America | 31 Participants |
| Estimated glomerular filtration rate (eGFR) | 84.2 mL/min/1.73m^2 STANDARD_DEVIATION 18.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 414 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Height | 170.99 Centimeter STANDARD_DEVIATION 9.17 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 111 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 310 Participants |
| Sex: Female, Male Female | 129 Participants |
| Sex: Female, Male Male | 297 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 426 |
| other Total, other adverse events | 47 / 426 |
| serious Total, serious adverse events | 1 / 426 |
Outcome results
Primary
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Specificity Based on the Blinded Readers' Assessment
Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=70% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was prospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Specificity Based on the Blinded Readers' Assessment | Reader 1 | 82.8 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Specificity Based on the Blinded Readers' Assessment | Reader 2 | 91.0 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Specificity Based on the Blinded Readers' Assessment | Reader 3 | 90.7 Specificity % |
Primary
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Specificity Based on the Blinded Readers' Assessment
Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Specificity= true negative/ (true negative + false positive).
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Specificity Based on the Blinded Readers' Assessment | Reader 1 | 85.1 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Specificity Based on the Blinded Readers' Assessment | Reader 2 | 92.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Specificity Based on the Blinded Readers' Assessment | Reader 3 | 91.9 Specificity % |
Primary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Sensitivity Based on the Blinded Readers' Assessment
Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=70% for secondary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: FAS: participants who underwent pharmacologic stress and for whom electronic case report form (eCRF) entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Sensitivity Based on the Blinded Readers' Assessment | Reader 1 | 89.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Sensitivity Based on the Blinded Readers' Assessment | Reader 2 | 79.6 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Sensitivity Based on the Blinded Readers' Assessment | Reader 3 | 78.7 Sensitivity % |
Primary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment
Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative).
Time frame: 0 to 30/40 minute (min) post-injection
Population: Full analysis set (FAS): participants who underwent pharmacologic stress and for whom electronic case report form entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment | Reader 1 | 76.6 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment | Reader 2 | 65.2 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment | Reader 3 | 64.5 Sensitivity % |
Primary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=70% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Gadobutrol-enhanced CMRI-Reader 1 | 89.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Gadobutrol-enhanced CMRI-Reader 2 | 79.6 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Gadobutrol-enhanced CMRI-Reader 3 | 78.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Unenhanced CMRI-Reader 1 | 82.4 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Unenhanced CMRI-Reader 2 | 45.4 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Unenhanced CMRI-Reader 3 | 48.1 Sensitivity % |
Comparison: Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.p-value: 0.0455McNemar 1-sided test,alpha level of 2.5%
Comparison: Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.p-value: <0.0001McNemar 1-sided test,alpha level of 2.5%
Comparison: Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.p-value: <0.0001McNemar 1-sided test,alpha level of 2.5%
Primary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative).
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Gadobutrol-enhanced CMRI-Reader 1 | 76.6 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Gadobutrol-enhanced CMRI-Reader 2 | 65.2 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Gadobutrol-enhanced CMRI-Reader 3 | 64.5 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Unenhanced CMRI-Reader 1 | 77.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Unenhanced CMRI-Reader 2 | 36.2 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Unenhanced CMRI-Reader 3 | 40.4 Sensitivity % |
Comparison: Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.p-value: 0.8694McNemar 1-sided test,alpha level of 2.5%
Comparison: Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.p-value: <0.0001McNemar 1-sided test,alpha level of 2.5%
Comparison: Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.p-value: <0.0001McNemar 1-sided test,alpha level of 2.5%
Secondary
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Investigator's Assessment
Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of \>=70% by QCA, which were secondary analysis. Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was prospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Investigator's Assessment | 85.0 Specificity % |
Secondary
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Investigator's Assessment
Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of \>=50% by QCA, which were secondary analysis. Specificity= true negative/ (true negative + false positive).
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Investigator's Assessment | 85.9 Specificity % |
Secondary
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI in participants with significant left main stem (LMS) stenosis and the myocardial perfusion defect pattern was described. If \>=1 myocardial region showed a myocardial perfusion defect with a RPS of \>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=50%). Sensitivity= true positive/ (true positive + false negative).
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR in the LMS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | Isolated, Investigator | 0 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | Isolated, Reader 1 | 1 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | Single-vessel, Reader 1 | 2 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | 2-vessel, Reader 1 | 1 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | 3-vessel, Reader 1 | 3 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | Isolated, Reader 2 | 0 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | Single-vessel, Reader 2 | 2 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | 2-vessel, Reader 2 | 1 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | 3-vessel, Reader 2 | 3 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | Isolated, Reader 3 | 0 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | Single-vessel, Reader 3 | 2 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | 2-vessel, Reader 3 | 1 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | 3-vessel, Reader 3 | 3 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | Single-vessel, Investigator | 2 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | 2-vessel, Investigator | 2 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments | 3-vessel, Investigator | 3 Participants |
Secondary
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=70%), if \>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of sensitivity was prospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Reader 1 | 70.6 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Reader 2 | 52.9 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Reader 3 | 56.9 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Investigator | 68.6 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Reader 1 | 90.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Reader 2 | 78.2 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Reader 3 | 80.5 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Investigator | 88.5 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Reader 1 | 90.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Reader 2 | 80.6 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Reader 3 | 82.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Investigator | 83.9 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Reader 1 | 77.1 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Reader 2 | 50.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Reader 3 | 50.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Investigator | 70.8 Sensitivity % |
Secondary
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=70%), if \>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of specificity was prospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Reader 1 | 90.0 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Reader 2 | 95.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Reader 3 | 91.1 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Investigator | 86.7 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Reader 1 | 85.7 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Reader 2 | 92.9 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Reader 3 | 91.8 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Investigator | 91.8 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Reader 1 | 74.8 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Reader 2 | 87.1 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Reader 3 | 85.0 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Investigator | 85.5 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Reader 1 | 78.7 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Reader 2 | 85.8 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Reader 3 | 87.2 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Investigator | 87.9 Specificity % |
Secondary
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Sensitivity was calculated coronary territory based, a coronary territory (left anterior descending artery \[LAD\] / non-LAD / right coronary artery \[RCA\] / left circumflex artery \[LCX\]) was rated positive for significant CAD (significant CAD defined as QCA stenosis of\>=50%), if \>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \>=1. A coronary territory(LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator.
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Reader 1 | 43.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Reader 2 | 31.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Reader 3 | 34.4 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Investigator | 45.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Reader 1 | 84.5 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Reader 2 | 68.9 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Reader 3 | 71.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Investigator | 76.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Reader 1 | 85.5 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Reader 2 | 69.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Reader 3 | 69.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Investigator | 71.1 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Reader 1 | 69.4 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Reader 2 | 48.6 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Reader 3 | 47.2 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Investigator | 55.6 Sensitivity % |
Secondary
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=50%), if \>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator.
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Reader 1 | 92.8 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Reader 2 | 97.1 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Reader 3 | 93.5 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LAD territory: Investigator | 91.2 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Reader 1 | 91.9 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Reader 2 | 97.7 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Reader 3 | 96.5 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to non-LAD territory: Investigator | 95.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Reader 1 | 82.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Reader 2 | 91.1 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Reader 3 | 87.9 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to RCA territory: Investigator | 87.7 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Reader 1 | 88.9 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Reader 2 | 94.4 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Reader 3 | 95.4 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments | Localization to LCX territory: Investigator | 93.5 Specificity % |
Secondary
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Score for confidence in diagnosis (not confident, somewhat confident, and confident) was described descriptively for each of the 6 myocardial regions. The frequency over the worst confidence in diagnosis obtained within a participant was displayed. All these analyses were done separately for gadobutrol-enhanced CMRI and unenhanced wall motion CMRI.
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Reader 1: Confident | 74.7 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Reader 1: Somewhat confident | 15.7 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Reader 1: Not confident | 9.6 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Reader 1: Missing | 0 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Reader 2: Confident | 86.4 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Reader 2: Somewhat confident | 12.8 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Reader 2: Not confident | 0.8 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Reader 2: Missing | 0 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Reader 3: Confident | 63.0 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Reader 3: Somewhat confident | 36.4 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Reader 3: Not confident | 0.5 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Reader 3: Missing | 0 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Investi.: Confident | 91.2 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Investi.: Somewhat confident | 8.2 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Investi.: Not confident | 0.3 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Unenhanced/Investi.: Missing | 0.3 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Reader 1: Confident | 88.3 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Reader 1: Somewhat confident | 8.2 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Reader 1: Not confident | 3.5 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Reader 1: Missing | 0 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Reader 2: Confident | 75.5 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Reader 2: Somewhat confident | 23.4 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Reader 2: Not confident | 1.1 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Reader 2: Missing | 0 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Reader 3: Confident | 74.7 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Reader 3: Somewhat confident | 23.7 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Reader 3: Not confident | 1.6 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Reader 3: Missing | 0 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Investi.: Confident | 79.0 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Investi.: Somewhat confident | 19.1 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Investi.: Not confident | 1.3 Percentage of Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments | Gadobutrol-enhanced/Investi.: Missing | 0.5 Percentage of Participants |
Secondary
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Sensitivity was calculated for detection of myocardial perfusion defects (MPD) on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If \>=1 myocardial region showed a myocardial perfusion defect with a RPS of \>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=50%). Sensitivity= true positive/ (true positive + false negative).
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Single-vessel disease - Reader 1 | 56.1 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Single-vessel disease - Reader 2 | 50.9 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Single-vessel disease - Reader 3 | 49.1 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Single-vessel disease - Investigator | 57.1 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Multi-vessel disease - Reader 1 | 92.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Multi-vessel disease - Reader 2 | 76.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Multi-vessel disease - Reader 3 | 76.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Multi-vessel disease - Investigator | 86.7 Sensitivity % |
Secondary
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Sensitivity was calculated for detection of MPD on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If \>=1 myocardial region showed a myocardial perfusion defect with a RPS of \>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Single-vessel disease - Reader 1 | 85.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Single-vessel disease - Reader 2 | 76.5 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Single-vessel disease - Reader 3 | 76.5 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Single-vessel disease - Investigator | 86.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Multi-vessel disease - Reader 1 | 97.5 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Multi-vessel disease - Reader 2 | 85.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Multi-vessel disease - Reader 3 | 82.5 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments | Multi-vessel disease - Investigator | 95.0 Sensitivity % |
Secondary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment
Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (significant CAD defined as QCA stenosis of \>=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment | 89.8 Sensitivity % |
Secondary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Investigator's Assessment
Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (significant CAD defined as QCA stenosis of \>=50%). Sensitivity= true positive/ (true positive + false negative).
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Investigator's Assessment | 74.3 Sensitivity % |
Secondary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment
Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based sensitivity and specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of \>=70% by QCA, which were secondary analysis. Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment | Gadobutrolenhanced:True Positive(Sensitivity) | 89.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment | Unenhanced: True Positive (Sensitivity) | 57.4 Sensitivity % |
Secondary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment
Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based sensitivity and specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of \>=50% by QCA, which were secondary analysis. Sensitivity= true positive/ (true positive + false negative).
Time frame: 0 to 30/40 min post-injection
Population: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment | Gadobutrol-enhanced CMRI | 74.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment | Unenhanced CMRI | 46.4 Sensitivity % |
Comparison: Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least \>=50% by QCA.p-value: <0.000195% CI: [18.5, 35.8]McNemar 2-sided test,alpha level of 5%
Comparison: Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least \>=50% by QCA.p-value: <0.000195% CI: [19.9, 34.4]McNemar 2-sided test,alpha level of 10%