Coronary Artery Disease Clinical Trial
Official title:
Multicenter Open-label Study to Evaluate Efficacy of Gadobutrol-enhanced 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
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).
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