15961 GadaCAD1
Research type
Research Study
Full 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
IRAS ID
116361
Contact name
Gerry McCann
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2012-002563-10
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Coronary Heart Disease (CHD) is a major cause of morbidity and mortality worldwide. In 2010, approximately 38,000 men and 27,000 women died from CHD; causing more deaths in England than any other single disease. CHD is a narrowing of the small blood vessels that supply blood and oxygen to the heart. CHD is also called coronary artery disease (CAD).
As well as angina (chest pain), the main symptoms of CAD are heart attacks and heart failure. However, not everyone has the same symptoms and some people may not have any before CAD is diagnosed. Early recognition of these symptoms and prompt treatment is essential for prevention of death and disability related CAD. In patients with known or suspected CAD, a variety of tests are used to assess presence or absence and severity of CAD, to risk stratify patients, and to plan clinical management accordingly.
Subjects being evaluated for suspected or known CAD based on signs and/or (typical or atypical) chest pain, 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.
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 routine Computed Tomography Angiography (CTA) for the clinical purpose of exclusion of CAD, 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.
CMRI and CA/CTA images will be collected for an independent image review (blinded read).
The study is planned to be performed in approximately 30 centers in the US, Europe, New Zealand and South Korea. A total of approximately 450 patients are expected to be included in the trial. In the UK there will be up to 6 centers, each will recruit a maximum of 45 patients.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0149
Date of REC Opinion
11 Jun 2013
REC opinion
Further Information Favourable Opinion