Design and rationale of "a pragmatic approach to the investigation of stable chest pain: a UK, multi-centre, randomised trial to assess patient outcomes, quality of life and cost effectiveness (CE-MARC 3)"

Abstract

Rationale: The optimal noninvasive diagnostic imaging strategy for patients with suspected coronary artery disease (CAD) is widely debated. Computed Tomography Coronary Angiography (CTCA) and functional imaging are both guideline-recommended, although comparative effectiveness in patients with intermediate-high pretest likelihood (PTL) is limited. Primary Hypothesis: We aim to establish if a personalized investigation strategy compared to CTCA first-line for allcomers, leads to improved patient outcomes. Design: In a multi-center, randomized trial, 4,000 patients newly referred for the investigation of suspected cardiac chest pain will be recruited and randomized (1:1) to either personalized care (first-line CTCA or functional imaging based on PTL) or CTCA first-line for allcomers. The primary endpoint is time to a composite of cardiovascular death, myocardial infarction, or unobstructed coronary arteries on invasive angiography. Follow up will occur at 6 and 12 months and then annually for up to 4 years for symptoms, quality of life, and guideline directed medical therapy usage. A cost-effectiveness analysis will be performed capturing impacts on health, measured in quality adjusted life years (QALYs) using the EQ-5D-5L, and costs (including investigations, procedures, procedural complications, medical treatment costs and any future hospital admissions) calculated. It will be possible for the whole trial pathway to be conducted remotely with the option to perform non-face-to-face consent, randomization, and follow-up data collection including health-related quality of life. Sites: About 20 UK sites. Enrolment: First site opened April 2022 and recruitment is due to complete by July 2025, with an average recruitment of 135 patients a month to date. Current status: About 3,407 patients recruited and randomized by the end of February 2025 Conclusion: This trial will address whether, in patients with suspected cardiac chest pain, a strategy of personalized investigation according to pretest likelihood (PTL), compared to CTCA for allcomers, leads to improved patient outcomes, quality of life and cost-effectiveness.

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ORCID for Nick Curzen: orcid.org/0000-0001-9651-7829

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