Coronary Artery Disease
Conditions
Keywords
Myocardial Perfusion Imaging
Brief summary
Subjects 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 subject in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. The primary objective of this study is to demonstrate that sensitivity and specificity of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD. The CMR images acquired with a uniform imaging acquisition software will be evaluated either against the results from routine clinical Coronary Angiography (CA) or Computed Tomography Angiography (CTA), which are the standard of reference. CMRI and CA/CTA images will be collected for an independent image review (blinded read).
Interventions
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 subjects aged ≥18 years * Subjects with suspected or known CAD based on signs and/or (typical or atypical) chest pain who have routine CA without intervention within plus/minus 4 weeks of gadobutrol-enhanced CMRI or subjects at low risk of CAD with / or scheduled to get a CTA for the purpose of exclusion of CAD within plus/minus 6 weeks of gadobutrol-enhanced CMRI * Willingness to undergo unenhanced wall motion and gadobutrol-enhanced CMRI at stress/rest and gated single photon emission computed tomography (GSPECT, if GSPECT will be a study procedure) * Women of childbearing potential (e.g. age \< 60y, no history of surgical sterilization or hysterectomy): use of contraception and a negative pregnancy test * Subjects who are scheduled for / have undergone routine GSPECT or undergo GSPECT as a study procedure at stress and at rest within ± 4 weeks of gadobutrol-enhanced CMRI
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 subject 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 - Primary Analysis of Sensitivity Based on 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 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. 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, coronary angiography \[CA\] or computed tomography angiography \[CTA, only if disease can be unequivocally rejected\]). 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 Based on 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 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. Significant CAD was defined as QCA stenosis of \>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. |
| Absence of Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Specificity Based on 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 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. Significant CAD was defined as QCA stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). 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 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 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. Significant CAD was defined as QCA stenosis of \>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective 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 QCA stenosis of \>=50% for primary analysis, and 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 (CA or CTA \[only if disease can be unequivocally rejected\]). 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 QCA stenosis of \>=70%, and 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 (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the 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 defined as QCA stenosis of \>=70%, and 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 (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. |
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT - Secondary Analysis of Sensitivity Comparison Based on Majority Blinded Reader's and Investigator's Assessment | 0 to 30/40 min post-injection | Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader (BR) and investigator's assessment. Significant CAD was defined as QCA stenosis of \>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. |
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity Based on Majority Blinded Reader's and Investigator's Assessment | 0 to 30/40 min post-injection | Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of \>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. |
| Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT -- Secondary Analysis of Specificity Comparison Based on Majority Blinded Reader's and Investigator's Assessment | 0 to 30/40 min post-injection | Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of \>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Specificity= true negative/(true negative + false positive). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. |
| Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Specificity Based on Majority Blinded Reader's and Investigator's Assessment | 0 to 30/40 min post-injection | Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of \>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Specificity= true negative/(true negative + false positive). This additional secondary analysis of specificity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. |
| Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | 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, majority blinded reader and the investigator. |
| Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | 0 to 30/40 min post-injection | Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD) 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, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. |
| 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 | The investigator 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. Significant CAD was defined as QCA stenosis of \>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). |
| Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | 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 LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | 0 to 30/40 min post-injection | Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD) 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, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. |
| Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | 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 retrospective analysis. |
| Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessment | 0 to 30/40 min post-injection | Number of participants with myocardial perfusion defects on gadobutrol-enhanced CMRI was calculated 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%). |
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | 0 to 30/40 min post-injection | Sensitivity was calculated for detection of myocardial perfusion defects 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 of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator | 0 to 30/40 min post-injection | Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-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 retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. |
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator | 0 to 30/40 min post-injection | Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-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 retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. |
| Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | 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 retrospective analysis. |
| Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Investigator's Assessment | 0 to 30/40 min post-injection | The investigator 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. Significant CAD was defined as QCA stenosis of \>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. |
| Number 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 Assessment | 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. |
| 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 | The investigator 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. Significant CAD was defined as QCA stenosis of \>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). 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 | The investigator 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. Significant CAD was defined as QCA stenosis of \>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective 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 the 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 defined as QCA stenosis of \>=50%, and 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 (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). |
Countries
Australia, Canada, Singapore, United States
Participant flow
Recruitment details
The study was conducted at 24 centers across 4 countries, between 26 August 2013 (first patient first visit) and 06 August 2016 (last patient last visit).
Pre-assignment details
Overall, 504 participants signed the informed consent, of which 14 did not finish their baseline visit (7 screening failures, 7 dropouts). A total of 490 participants entered the diagnostic imaging phase, of them 478 participants were treated 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. | 478 |
| Total | 478 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Assessment discrepancy | 1 |
| Overall Study | Could not get whole set of images | 1 |
| Overall Study | CRC didn't contact participant for FU | 1 |
| Overall Study | Decline to return for GSPECT | 1 |
| Overall Study | GSPECT at rest was not done | 1 |
| Overall Study | Moved out of position | 1 |
| Overall Study | Participant didn't complete MRI | 1 |
| Overall Study | PCI at external hospital | 1 |
| Overall Study | Unable to contact | 1 |
| Overall Study | Uncontactable by phone | 1 |
| Overall Study | Withdrawal by PI for ICA not performed | 2 |
Baseline characteristics
| Characteristic | Gadobutrol 0.1 mmol/kg Body Weight |
|---|---|
| Age, Continuous | 58.6 Years STANDARD_DEVIATION 10.3 |
| Body mass index (BMI) | 29.4 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 5.5 |
| Body weight | 86.2 kilogram (kg) STANDARD_DEVIATION 18.6 |
| Childbearing potential No | 150 Participants |
| Childbearing potential Yes | 27 Participants |
| Estimated glomerular filtration rate (eGFR) | 82.0 mL/min/1.73m^2 STANDARD_DEVIATION 18.73 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 448 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Height | 170.9 centimeter (cm) STANDARD_DEVIATION 9.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 58 Participants |
| Race (NIH/OMB) Black or African American | 81 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 322 Participants |
| Region of Enrollment Australia | 71 Participants |
| Region of Enrollment Canada | 20 Participants |
| Region of Enrollment Singapore | 31 Participants |
| Region of Enrollment United States | 356 Participants |
| Sex: Female, Male Female | 177 Participants |
| Sex: Female, Male Male | 301 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 478 |
| other Total, other adverse events | 79 / 478 |
| serious Total, serious adverse events | 4 / 478 |
Outcome results
Primary
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity 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 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. Significant CAD was defined as QCA stenosis of \>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: Participants in 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 the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of \>= 70%) 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 - Additional Secondary Analysis of Specificity Based on Blinded Readers' Assessment | Reader 1 | 82.0 Specificity % |
| 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 Blinded Readers' Assessment | Reader 2 | 87.3 Specificity % |
| 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 Blinded Readers' Assessment | Reader 3 | 86.9 Specificity % |
Primary
Absence of Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Specificity 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 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. Significant CAD was defined as QCA stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Specificity= true negative/ (true negative + false positive).
Time frame: 0 to 30/40 min post-injection
Population: Participants in 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 the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of \>= 50%) as verified by SoR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Specificity Based on Blinded Readers' Assessment | Reader 1 | 85.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Specificity Based on Blinded Readers' Assessment | Reader 2 | 88.7 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Specificity Based on Blinded Readers' Assessment | Reader 3 | 89.5 Specificity % |
Primary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary 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 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. Significant CAD was defined as QCA stenosis of \>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: Participants in 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 the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \>= 70%) 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 - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' Assessment | Reader 1 | 77.1 Sensitivity % |
| 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 Based on Blinded Readers' Assessment | Reader 2 | 71.4 Sensitivity % |
| 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 Based on Blinded Readers' Assessment | Reader 3 | 76.2 Sensitivity % |
Primary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - 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 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. 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, coronary angiography \[CA\] or computed tomography angiography \[CTA, only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative).
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS (full analysis set, 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 the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \>= 50%) 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 - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment | Reader 1 | 64.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment | Reader 2 | 56.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment | Reader 3 | 61.3 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 QCA stenosis of \>=70%, and 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 (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: Participants in 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 the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \>= 70%) 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 | 77.1 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 | 71.4 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 | Gadobutrol-enhanced CMRI - Reader 3 | 76.2 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 - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Unenhanced CMRI - Reader 1 | 56.2 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 - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Unenhanced CMRI - Reader 2 | 35.2 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 - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Unenhanced CMRI - Reader 3 | 35.2 Sensitivity % |
Comparison: Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.p-value: 0.00005McNemar
Comparison: Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.p-value: <0.0001McNemar
Comparison: Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.p-value: <0.0001McNemar
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 QCA stenosis of \>=50% for primary analysis, and 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 (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative).
Time frame: 0 to 30/40 min post-injection
Population: Participants in 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 the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \>= 50%) 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 | 64.7 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 - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Gadobutrol-enhanced CMRI - Reader 2 | 56.0 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 | 61.3 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 1 | 48.0 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 | 30.0 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 | 29.3 Sensitivity % |
Comparison: Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.p-value: 0.00009McNemar
Comparison: Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.p-value: <0.0001McNemar
Comparison: Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.p-value: <0.0001McNemar
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
The investigator 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. Significant CAD was defined as QCA stenosis of \>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: Participants in 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 the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of \>= 70%) 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 | 81.7 Specificity % |
Secondary
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Specificity Based on Majority Blinded Reader's and Investigator's Assessment
Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of \>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Specificity= true negative/(true negative + false positive). This additional secondary analysis of specificity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS with significant CAD (defined as QCA stenosis of \>= 70%) as verified by SoR, for assessment on gadobutrol-enhanced CMRI, and available GSPECT for assessment on GSPECT.
| 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 and GSPECT - Additional Secondary Analysis of Specificity Based on Majority Blinded Reader's and Investigator's Assessment | Gadobutrol-enhanced CMRI - Majority blinded reader | 86.6 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Specificity Based on Majority Blinded Reader's and Investigator's Assessment | Gadobutrol-enhanced CMRI - Investigator | 81.7 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Specificity Based on Majority Blinded Reader's and Investigator's Assessment | GSPECT - Majority blinded reader | 78.9 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Specificity Based on Majority Blinded Reader's and Investigator's Assessment | GSPECT - Investigator | 73.6 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
The investigator 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. Significant CAD was defined as QCA stenosis of \>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Specificity= true negative/ (true negative + false positive).
Time frame: 0 to 30/40 min post-injection
Population: Participants in 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 the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of \>= 50%) 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 | 85.8 Specificity % |
Secondary
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT -- Secondary Analysis of Specificity Comparison Based on Majority Blinded Reader's and Investigator's Assessment
Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of \>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Specificity= true negative/(true negative + false positive). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS (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 the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of \>= 50%) as verified by SoR and available GSPECT.
| 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 Versus GSPECT -- Secondary Analysis of Specificity Comparison Based on Majority Blinded Reader's and Investigator's Assessment | Gadobutrol-enhanced CMRI - Majority BR | 92.1 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT -- Secondary Analysis of Specificity Comparison Based on Majority Blinded Reader's and Investigator's Assessment | Gadobutrol-enhanced CMRI - Investigator | 85.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT -- Secondary Analysis of Specificity Comparison Based on Majority Blinded Reader's and Investigator's Assessment | GSPECT - Majority BR | 81.0 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT -- Secondary Analysis of Specificity Comparison Based on Majority Blinded Reader's and Investigator's Assessment | GSPECT - Investigator | 77.5 Specificity % |
Comparison: Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by majority BR.p-value: 0.00195% CI: [4.1, 17]McNemar
Comparison: Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by investigator.p-value: 0.009495% CI: [1.6, 13.2]McNemar
Secondary
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessment
Number of participants with myocardial perfusion defects on gadobutrol-enhanced CMRI was calculated 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%).
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS with significant LMS stenosis indicating significant CAD (defined as QCA stenosis of \>= 50%) as verified by SoR.
| Arm | Measure | Group | Value (COUNT_OF_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 Assessment | 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 Assessment | Isolated - Majority BR | 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 Assessment | Single 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 Assessment | 2-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 Assessment | 3-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 Assessment | 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 Assessment | Single 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 Assessment | 2-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 Assessment | 3-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 Assessment | Isolated - 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 Assessment | Single 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 Assessment | 2-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 Assessment | 3-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 Assessment | Single vessel - Majority BR | 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 Assessment | 2-vessel - Majority BR | 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 Assessment | 3-vessel - Majority BR | 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 Assessment | Isolated - 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 Assessment | Single vessel - Investigator | 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 Assessment | 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 Assessment | 3-vessel - Investigator | 2 Participants |
Secondary
Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment
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 retrospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS with significant CAD (defined as QCA stenosis of \>= 70%) as verified by SoR in each coronary territory, with either blinded reading or investigator reading performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Reader 1 | 69.5 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Reader 2 | 71.2 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 1 | 74.6 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 2 | 58.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 3 | 63.5 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Investigator | 68.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 1 | 71.4 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 2 | 68.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 3 | 74.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Investigator | 81.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Reader 3 | 71.2 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Investigator | 79.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Reader 1 | 68.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Reader 2 | 43.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Reader 3 | 75.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Investigator | 66.7 Sensitivity % |
Secondary
Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment
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 retrospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS without significant CAD (defined as QCA stenosis of \>= 70%) as verified by SoR in each coronary territory, with either blinded reading or investigator reading.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 1 | 86.8 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 2 | 91.1 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 3 | 89.8 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Investigator | 85.6 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 1 | 79.1 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 2 | 85.5 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 3 | 83.0 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Investigator | 80.8 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Reader 1 | 83.0 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Reader 2 | 86.0 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Reader 3 | 84.5 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Investigator | 83.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Reader 1 | 82.6 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Reader 2 | 91.2 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Reader 3 | 85.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Investigator | 86.2 Specificity % |
Secondary
Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment
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, majority blinded reader and the investigator.
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS with significant CAD (defined as QCA stenosis of \>= 50%) as verified by SoR in each coronary territory.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 3 | 63.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Investigator | 67.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Reader 1 | 56.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Reader 2 | 31.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 1 | 63.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 2 | 54.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Majority BR | 61.1 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Reader 2 | 56.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Reader 3 | 60.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Investigator | 68.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Reader 1 | 57.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Reader 3 | 53.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Investigator | 48.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 1 | 54.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 2 | 40.4 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 3 | 46.2 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Majority BR | 48.1 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Investigator | 52.9 Sensitivity % |
Secondary
Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment
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: Participants in FAS without significant CAD (defined as QCA stenosis of \>= 50% by) as verified by SoR in each coronary territory, with either blinded reading or investigator reading performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 1 | 83.6 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 1 | 89.9 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 2 | 92.4 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 3 | 92.4 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Majority BR | 92.4 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Investigator | 89.9 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 2 | 87.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 3 | 87.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Majority | 86.9 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Investigator | 84.8 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Reader 1 | 84.1 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Reader 2 | 86.7 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Reader 3 | 86.4 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to RCA territory - Investigator | 86.1 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Reader 1 | 86.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Reader 2 | 92.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Reader 3 | 87.3 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LCX territory - Investigator | 89.0 Specificity % |
Secondary
Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment
Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD) 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, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS with significant CAD (defined as QCA stenosis of \>= 50%) as verified by SoR and available GSPECT in each coronary territory, with either blinded reading or investigator reading performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 8 | 32.9 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 9 | 31.4 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 10 | 37.1 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Majority BR | 31.4 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Investigator | 43.9 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 8 | 58.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 9 | 45.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 10 | 45.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Majority BR | 48.1 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Investigator | 64.2 Sensitivity % |
Secondary
Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment
Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD) 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, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS without significant CAD (defined as QCA stenosis of \>= 50%) as verified by SoR and available GSPECT in each coronary territory, with either blinded reading or investigator reading,
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 9 | 85.1 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 8 | 88.6 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 9 | 89.5 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Reader 10 | 90.9 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Majority BR | 91.8 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to LAD territory - Investigator | 88.0 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 8 | 75.0 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Reader 10 | 88.0 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Majority BR | 85.6 Specificity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Localization to non-LAD territory - Investigator | 81.1 Specificity % |
Secondary
Number 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 Assessment
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Reader 1 | Confident | 310 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Reader 1 | Somewhat confident | 74 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Reader 1 | Not confident | 4 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Reader 1 | Missing | 1 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Reader 2 | Confident | 300 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Reader 2 | Somewhat confident | 71 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Reader 2 | Not confident | 17 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Reader 2 | Missing | 1 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Reader 3 | Confident | 186 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Reader 3 | Somewhat confident | 155 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Reader 3 | Not confident | 47 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Reader 3 | Missing | 1 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Investigator | Confident | 274 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Investigator | Somewhat confident | 98 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Investigator | Not confident | 17 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Gadobutrol-enhanced CMRI - Investigator | Missing | 0 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Reader 1 | Confident | 315 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Reader 1 | Somewhat confident | 72 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Reader 1 | Not confident | 1 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Reader 1 | Missing | 1 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Reader 2 | Confident | 290 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Reader 2 | Somewhat confident | 84 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Reader 2 | Not confident | 14 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Reader 2 | Missing | 1 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Reader 3 | Confident | 329 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Reader 3 | Somewhat confident | 44 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Reader 3 | Not confident | 15 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Reader 3 | Missing | 1 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Investigator | Confident | 341 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Investigator | Somewhat confident | 46 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Investigator | Not confident | 2 Participants |
| Gadobutrol 0.1 mmol/kg Body Weight | Number 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 Assessment | Unenhanced CMRI - Investigator | Missing | 0 Participants |
Secondary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator
Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-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 retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS with multi-vessel disease indicating significant CAD (defined as QCA stenosis of \>=70%) 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 in Participants With Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator | Gadobutrol-enhanced CMRI - Majority BR | 81.1 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator | Gadobutrol-enhanced CMRI - Investigator | 90.5 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator | GSPECT - Majority BR | 77.6 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator | GSPECT - Investigator | 89.9 Sensitivity % |
Secondary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment
Sensitivity was calculated for detection of myocardial perfusion defects 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: Participants in 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 the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \>= 50%) 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 in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Multi-vessel - Reader 2 | 72.6 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Single-vessel - Reader 1 | 45.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Single-vessel - Reader 2 | 32.2 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Single-vessel - Reader 3 | 39.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Single-vessel - Investigator | 45.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Multi-vessel - Reader 1 | 77.4 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Multi-vessel - Reader 3 | 77.4 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Multi-vessel - Investigator | 88.1 Sensitivity % |
Secondary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator
Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-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 retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS with single-vessel disease indicating significant CAD (defined as QCA stenosis of \>= 70%) 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 in Participants With Single-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator | Gadobutrol-enhanced CMRI - Majority BR | 66.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator | Gadobutrol-enhanced CMRI - Investigator | 70.4 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator | GSPECT - Majority BR | 21.1 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator | GSPECT - Investigator | 61.5 Sensitivity % |
Secondary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Investigator's Assessment
The investigator 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. Significant CAD was defined as QCA stenosis of \>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: Participants in 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 the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \>= 70%) 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 Based on Investigator's Assessment | 85.7 Sensitivity % |
Secondary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity Based on Majority Blinded Reader's and Investigator's Assessment
Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of \>=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS with significant CAD (defined as QCA stenosis of \>= 70%) as verified by SoR, for assessment on gadobutrol-enhanced CMRI, and available GSPECT for assessment on GSPECT.
| 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 and GSPECT - Additional Secondary Analysis of Sensitivity Based on Majority Blinded Reader's and Investigator's Assessment | Gadobutrol-enhanced CMRI - Majority BR | 78.8 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity Based on Majority Blinded Reader's and Investigator's Assessment | Gadobutrol-enhanced CMRI - Investigator | 86.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity Based on Majority Blinded Reader's and Investigator's Assessment | GSPECT - Majority BR | 64.9 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity Based on Majority Blinded Reader's and Investigator's Assessment | GSPECT - Investigator | 83.0 Sensitivity % |
Secondary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the 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 defined as QCA stenosis of \>=70%, and 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 (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.
Time frame: 0 to 30/40 min post-injection
Population: Participants in 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 the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \>= 70%) 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 and Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Investigator's Assessment | Gadobutrol-enhanced CMRI | 85.7 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Investigator's Assessment | Unenhanced CMRI | 61.0 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
The investigator 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. Significant CAD was defined as QCA stenosis of \>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative).
Time frame: 0 to 30/40 min post-injection
Population: Participants in 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 the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \>= 50%) 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 | 72.0 Sensitivity % |
Secondary
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT - Secondary Analysis of Sensitivity Comparison Based on Majority Blinded Reader's and Investigator's Assessment
Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader (BR) and investigator's assessment. Significant CAD was defined as QCA stenosis of \>=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.
Time frame: 0 to 30/40 min post-injection
Population: Participants in FAS (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 the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \>= 50%) as verified by SoR and available GSPECT.
| 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 GSPECT - Secondary Analysis of Sensitivity Comparison Based on Majority Blinded Reader's and Investigator's Assessment | Gadobutrol-enhanced CMRI - Majority BR | 60.0 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT - Secondary Analysis of Sensitivity Comparison Based on Majority Blinded Reader's and Investigator's Assessment | Gadobutrol-enhanced CMRI - Investigator | 72.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT - Secondary Analysis of Sensitivity Comparison Based on Majority Blinded Reader's and Investigator's Assessment | GSPECT - Majority BR | 54.3 Sensitivity % |
| Gadobutrol 0.1 mmol/kg Body Weight | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT - Secondary Analysis of Sensitivity Comparison Based on Majority Blinded Reader's and Investigator's Assessment | GSPECT - Investigator | 72.3 Sensitivity % |
Comparison: Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by majority BR.p-value: 0.273395% CI: [-5.4, 14.9]McNemar
Comparison: Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by investigator.p-value: 195% CI: [-8.6, 7.2]McNemar
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 the 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 defined as QCA stenosis of \>=50%, and 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 (CA or CTA \[only if disease can be unequivocally rejected\]). Sensitivity= true positive/ (true positive + false negative).
Time frame: 0 to 30/40 min post-injection
Population: Participants in 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 the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of \>= 50%) 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 the Investigator's Assessment | Gadobutrol-enhanced CMRI | 72.0 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 the Investigator's Assessment | Unenhanced CMRI | 50.7 Sensitivity % |
Comparison: Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI.p-value: <0.000195% CI: [12.9, 28.4]McNemar
p-value: <0.000190% CI: [14.2, 27.2]McNemar