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- Open Access
Rationale and design of the Clinical Evaluation of MAgnetic Resonance imaging in Coronary heart disease 2 trial (CE-MARC 2): A prospective, multi-centre, randomized controlled trial of diagnostic strategies for suspected coronary heart disease
© Ripley et al. 2016
- Published: 27 January 2016
- Single Photon Emission Compute Tomography
- Cardiovascular Magnetic Resonance
- Fractional Flow Reserve
- Diagnostic Strategy
- Major Adverse Cardiovascular Event
A number of investigative strategies exist for the diagnosis of coronary heart disease (CHD). Despite the widespread availability of non-invasive imaging, invasive angiography is commonly used early in the diagnostic pathway. Consequently, approximately 60% of angiograms reveal no evidence of obstructive coronary disease. Reducing unnecessary angiography has potential financial savings and avoids exposing the patient to unnecessary risk. There are no large scale comparative effectiveness trials of the different diagnostic strategies recommended in international guidelines and none that have evaluated the safety and efficacy of cardiovascular magnetic resonance (CMR).
CE-MARC 2 is a prospective, multi-centre, 3-arm parallel group, randomized controlled trial of patients with suspected CHD (pre-test likelihood 10-90%) requiring further investigation. 1200 patients will be randomized on a 2:2:1 basis to receive 3.0 Tesla CMR-guided care, single photon emission computed tomography (SPECT) guided care (according to ACC/AHA appropriate-use criteria) or National Institute for Health and Care Excellence guidelines-based management. The primary (efficacy) endpoint is the occurrence of unnecessary angiography as defined by a normal (>0.8) invasive fractional flow reserve. Safety of each strategy will be assessed by 3-year major adverse cardiovascular event rates. Cost effectiveness and health related quality of life (HRQoL) measures will be performed.
The CE-MARC 2 trial will provide comparative efficacy and safety evidence for three different strategies of investigating patient with suspected CHD, with the intension of reducing unnecessary invasive angiography rates.
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