Rationale and design of the British Heart Foundation (BHF) Coronary Microvascular Angina (CorMicA) stratified medicine clinical trial

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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Berry, Professor Colin and McConnachie, Dr Alex and Padmanabhan, Professor Sandosh and Brooksbank, Dr Katriona and Ford, Thomas and McEntegart, Dr Margaret and Briggs, Professor Andrew and Corcoran, Dr David and Oldroyd, Dr Keith and Sattar, Professor Naveed and Touyz, Professor Rhian
Authors: Ford, T. J., Corcoran, D., Oldroyd, K. G., McEntegart, M., Rocchiccioli, P., Watkins, S., Brooksbank, K., Padmanabhan, S., Sattar, N., Briggs, A., McConnachie, A., Touyz, R., and Berry, C.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
Journal Name:American Heart Journal
Publisher:Elsevier
ISSN:0002-8703
ISSN (Online):1097-6744
Published Online:03 April 2018
Copyright Holders:Copyright © 2018 The Authors
First Published:First published in American Heart Journal 201: 86-94
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
617771BHF centre of excellenceRhian TouyzBritish Heart Foundation (BHF)RE/13/5/30177RI CARDIOVASCULAR & MEDICAL SCIENCES
3014540CORonary MICrovascular Angina (CorMicA): a pilot trial with a nested MRI sub-studyColin BerryBritish Heart Foundation (BHF)PG/17/25/32884CAMS - Cardiovascular Science