Ford, T. J. et al. (2018) Rationale and design of the British Heart Foundation (BHF) Coronary Microvascular Angina (CorMicA) stratified medicine clinical trial. American Heart Journal, 201, pp. 86-94. (doi: 10.1016/j.ahj.2018.03.010) (PMID:29803987) (PMCID:PMC6018570)
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Abstract
Background: Coronary angiography is performed to assess for obstructive coronary artery disease (CAD) but “non-obstructive CAD” is a common finding. Microvascular or vasospastic angina may be relevant, but routine confirmatory testing is not evidence-based and thus rarely performed. Aim: To assess the effect of stratified medicine guided by coronary function testing on the diagnosis, treatment and well-being of patients with angina and non-obstructive CAD. Design: The BHF CorMicA trial is a prospective, multicenter, randomized, blinded, sham-controlled trial of stratified medicine (NCT03193294). All-comers referred for elective coronary angiography for investigation of suspected CAD will be screened. Following informed consent, eligible patients with angina and non-obstructive CAD will be randomized 1:1 immediately in the catheter laboratory to either coronary artery function guided diagnosis and treatment (intervention group) or not (control group). Coronary function will be assessed using a pressure-temperature sensitive guidewire followed by pharmacological testing with intra-coronary acetylcholine. Patients will be stratified into endotypes with linked therapy. The primary outcome is change in Seattle Angina Questionnaire (SAQ) score at 6 months. Secondary outcomes include safety, feasibility, diagnostic utility (impact on diagnosis and diagnostic certainty) and clinical utility (impact on treatment and investigations). Health status is a key secondary outcome assessed according to the following domains: quality of life, treatment satisfaction, illness perception, physical activity and anxiety-depression score. Patients with obstructive disease who are not randomized will form a registry group who will be followed up as a comparator for secondary outcomes including health status. Health and economic outcomes will be evaluated in the longer term using electronic health record linkage. Value: CorMicA is a proof-of-concept clinical trial of a disruptive stratified intervention with potential benefits to patients and healthcare providers.
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