- Poster presentation
- Open Access
- Published:
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
Journal of Cardiovascular Magnetic Resonance volume 18, Article number: P75 (2016)
Background
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).
Methods
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.
Results
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.
Conclusions
Evaluation of these management strategies has the potential to improve patient care, HRQoL and the cost effectiveness of CHD investigation.
CE-MARC 2 study flow diagram illustrating randomization, investigative strategy and study end-points.
Author information
Authors and Affiliations
Rights and permissions
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.
The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.
To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/.
The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
About this article
Cite this article
Ripley, D.P., Brown, J., Everett, C.C. et al. 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. J Cardiovasc Magn Reson 18 (Suppl 1), P75 (2016). https://doi.org/10.1186/1532-429X-18-S1-P75
Published:
DOI: https://doi.org/10.1186/1532-429X-18-S1-P75
Keywords
- Single Photon Emission Compute Tomography
- Cardiovascular Magnetic Resonance
- Fractional Flow Reserve
- Diagnostic Strategy
- Major Adverse Cardiovascular Event