Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
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).
Timeline
- Start
- 2013-08-26
- Primary completion
- 2016-08-06
- Completion
- 2016-11-10
Outcome
Met primary endpoint
registry analysis (superiority test); Gadobutrol 0.1 mmol/kg Body Weight; p = 0.00009; Sensitivity Difference 16.7; McNemar NCT01890434 ↗
registry analysis (superiority test); Gadobutrol 0.1 mmol/kg Body Weight; p <0.0001; Sensitivity Difference 26.0; McNemar NCT01890434 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gadobutrol | Diagnostic / imaging agent | 0.1 unknown | — |