title: 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.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Multidisciplinary Cardiovascular Research Centre (MCRC) & Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
authors.forename: David P
authors.initials: DP
authors.lastname: Ripley
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
authors.forename: Julia M
authors.initials: JM
authors.lastname: Brown
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
authors.forename: Colin C
authors.initials: CC
authors.lastname: Everett
authors.affiliation: Multidisciplinary Cardiovascular Research Centre (MCRC) & Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
authors.forename: Petra
authors.initials: P
authors.lastname: Bijsterveld
authors.affiliation: Centre for Health Economics, University of York, York, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Walker
authors.affiliation: Centre for Health Economics, University of York, York, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Sculpher
authors.affiliation: Department of Cardiovascular Sciences, University of Leicester, and the National Institute of Health Research Leicester Cardiovascular Biomedical Research Unit, Leicester, UK.
authors.forename: Gerry P
authors.initials: GP
authors.lastname: McCann
authors.affiliation: BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
authors.forename: Colin
authors.initials: C
authors.lastname: Berry
authors.affiliation: Multidisciplinary Cardiovascular Research Centre (MCRC) & Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
authors.forename: Sven
authors.initials: S
authors.lastname: Plein
authors.affiliation: Multidisciplinary Cardiovascular Research Centre (MCRC) & Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK. Electronic address: j.greenwood@leeds.ac.uk.
authors.forename: John P
authors.initials: JP
authors.lastname: Greenwood
mesh_terms: D017023:Coronary Angiography / Q000706:statistics & numerical data; D003327:Coronary Disease / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000191:economics; D003362:Cost-Benefit Analysis; D006801:Humans; D019028:Magnetic Resonance Imaging, Cine / Q000191:economics / Q000379:methods*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018570:Risk Assessment; D015899:Tomography, Emission-Computed, Single-Photon; D019564:Unnecessary Procedures / Q000706:statistics & numerical data