Multicenter open-label study to evaluate efficacy of gadobutrolenhanced cardiac magnetic resonance imaging (CMRI) for detection of significant coronary artery disease (CAD) in subjects with known or suspected CAD by a blinded image analysis
The primary efficacy objectives of this study are to demonstrate that sensitivity and specificity of gadobutrol-enhanced CMRI exceed prespecified 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 coronary artery disease (CAD) in subjects with suspected or known CAD. The study is comparing the diagnostic ability of stress cardiac MRI (CMR) using this contrast agent as compared to coronary angiogram and gated SPECT.
- Study Identifier: 818179
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