Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
Status:
Completed
Trial end date:
2017-08-31
Target enrollment:
Participant gender:
Summary
Participants 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
participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study
doctor will be required.
This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic
Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion
(specificity) of coronary artery disease utilizing a uniform image acquisition software. The
CMR images will be tested either against the results from routine clinical Coronary
Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the
standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment
or be scheduled up to 4/6 weeks after the study.
CMRI and CA/CTA images will be collected for an independent image review (blinded read).