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

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
Recruiting
1 years - 99 years
All
Phase 3
46 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Coronary heart disease, Coronary heart disease, coronary heart disease
  • Age: 1 years - 99 years
  • Gender: All
Updated on 19 Feb 2024. Study ID: 818179

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