Subjects with known or suspected Coronary Artery Disease (CAD)
Conditions
Interventions
Trade Name: Gadovist® 1.0mmol/ml, solution for injection
Product Name: Gadovist® 1.0 mmol/ml, solution for injection
Product Code: BAY 86-4875
Pharmaceutical Form: Solution for injection
INN or Propos
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 or CTA within 4 weeks around gadobutrol-enhanced CMRI - Willingness to undergo stress/rest CMRI and to follow directions and complete all study procedures - Women of childbearing potential (e.g. age =65 years) yes F.1.3.1 Number of subjects for this age range 315
Exclusion criteria
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 m2 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 |
|---|---|
| Main Objective: The primary efficacy objectives of this study are to demonstrate that sensitivity and specificity of gadobutrol-enhanced CMRI exceed pre-specified minimum performance thresholds (MPT) 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: Primary objectives (i.e. 3 co-primaries) are to 1) demonstrate that subject-based sensitivity of gadobutrol-enhanced CMRI at vasodilator stress/rest (lower bound of 95% CI) exceeds the predefined minimum performance threshold of 60%; 2) demonstrate that subject-based specificity of gadobutrol-enhanced CMRI at vasodilator stress/rest (lower bound of 95% CI) exceeds the predefined minimum performance threshold of 55%; 3) demonstrate subject-based superior sensitivity of gadobutrol-enhanced CMRI over unenhanced wall motion CMRI. ;Secondary Objective: 1) demonstrate that subject-based sensitivity and specificity, of gadobutrol-enhanced CMRI (lower bound of 95% CI) exceed 60% and 55%, respectively. 2) demonstrate subject-based superior sensitivity of gadobutrol-enhanced CMRI compared to unenhanced wall motion CMRI. 3) evaluate coronary territory-based sensitivity and specificity of gadobutrol-enhanced CMRI for localization of CAD; • for territories LAD and non-LAD; • additional localization for RCA and LCX; 4) evaluate detection and perfusion pattern of subjects with LMS stenosis; 5) evaluate subject-based sensitivity and specificity of gadobutrol- enhanced CMRI for detection and exclusion of significant CAD separately in 2 subgroups: -subjects with single-vessel disease and -subjects with multi-(2- or 3)-vessel disease. 6) assess the confidence of diagnosis for each defined myocardial region for unenhanced wall motion and gadobutrol-enhanced CMRI. 7) confirm the safety profile of gadobutrol in this indication. ;Primary end point(s): 1. Presence of a myocardial perfusion defect indicating significant CAD [coronar | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Presence of a myocardial perfusion defect indicating significant CAD per subject on gadobutrol-enhanced CMRI (investigator's assessment). 2. Absence of myocardial perfusion defect excluding significant CAD per subject on gadobutrol-enhanced CMRI (investigator's assessment). 3. Presence of a myocardial perfusion defect indicating significant CAD per subject on gadobutrol-enhanced CMRI versus unenhanced wall motion CMR images (investigator's assessment). 4. Localization of a myocardial perfusion defect to a coronary territory, i.e. LAD [left anterior descending artery] and non-LAD, on gadobutrol-enhanced CMRI (blinded readers' and investigator's assessments). 5. Additional localization of a non-LAD myocardial perfusion defect to RCA [right coronary artery] and LCX [left circumflex artery] territory respectively on gadobutrol-enhanced CMRI (blinded readers' and investigator's assessments). 6. Detection of subjects with LMS [left main stem] stenosis. 7. Perfusion pattern of subjects with LMS stenosis. 8. Presence/absence of a myocardial perfusion defect indicating/excluding significant CAD (per subject), in subjects with multi-vessel versus single vessel disease evaluated on gadobutrol-enhanced CMRI (blinded readers' and investigator's assessments). 9. Score for confidence of diagnosis for each myocardial region on unenhanced wall motion and gadobutrol-enhanced CMR images (blinded readers' and investigator's assessments).;Timepoint(s) of evaluation of this end point: Up to 8 weeks | — |
Countries
France, Germany, Korea, Republic of, New Zealand, Switzerland, United Kingdom, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed