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document
Rationale and design of the Clinical Evaluation of Magnetic Resonance Imaging in Coronary heart disease 2 trial ( CE-MARC 2 ) : a prospective , multicenter , randomized trial of diagnostic strategies in suspected coronary heart disease . BACKGROUND A number of investigative strategies exist for the diagnosis of coronary heart disease ( CHD ) . Despite the widespread availability of noninvasive 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 . TRIAL DESIGN CE-MARC 2 is a prospective , multicenter , 3-arm parallel group , randomized controlled trial of patients with suspected CHD ( pretest likelihood 10 % -90 % ) requiring further investigation . A total of 1,200 patients will be randomized on a 2:2:1 basis to receive 3.0-T cardiovascular magnetic resonance-guided care , single-photon emission computed tomography-guided care ( according to American College of Cardiology/American Heart Association appropriate-use criteria ) , or National Institute for Health and Care Excellence guidelines-based management . The primary ( efficacy ) end point 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 measures will be performed . CONCLUSIONS The CE-MARC 2 trial will provide comparative efficacy and safety evidence for 3 different strategies of investigating patients with suspected CHD , with the intension of reducing unnecessary invasive angiography rates . Evaluation of these management strategies has the potential to improve patient care , health-related quality of life , and the cost-effectiveness of CHD investigation .
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Intervention_Physical
Magnetic Resonance Imaging
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Intervention_Surgical
invasive angiography
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Intervention_Physical
3.0-T cardiovascular magnetic resonance-guided care , single-photon emission computed tomography-guided care
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Intervention_Educational
or National Institute for Health and Care Excellence guidelines-based management .
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Participant_Condition
suspected coronary heart disease
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Participant_Condition
suspected CHD ( pretest likelihood 10 % -90 % ) requiring further investigation
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Participant_Sample-size
1,200
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Participant_Condition
suspected CHD