The coronary microvascular angina cardiovascular magnetic resonance imaging trial: rationale and design

Bradley, C. P. et al. (2023) The coronary microvascular angina cardiovascular magnetic resonance imaging trial: rationale and design. American Heart Journal, (doi: 10.1016/j.ahj.2023.08.067) (In Press)

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Background: Coronary microvascular dysfunction may cause myocardial ischemia with no obstructive coronary artery disease (INOCA). If functional testing is not performed INOCA may pass undetected. Stress perfusion cardiovascular MRI (CMR) quantifies myocardial blood flow (MBF) but the clinical utility of stress CMR in the management of patients with suspected angina with no obstructive coronary arteries (ANOCA) is uncertain. Objectives: First, to undertake a diagnostic study using stress CMR in patients with ANOCA following invasive coronary angiography and, second, in a nested, double-blind, randomized, controlled trial to assess the effect of disclosure on the final diagnosis and health status in the longer term. Design: All-comers referred for clinically indicated coronary angiography for the investigation of suspected coronary artery disease will be screened in three regional centers in the United Kingdom. Following invasive coronary angiography, patients with ANOCA who provide informed consent will undergo noninvasive endotyping using stress CMR within 3 months of the angiogram. Diagnostic study: Stress perfusion CMR imaging to assess the prevalence of coronary microvascular dysfunction and clinically significant incidental findings in patients with ANOCA. The primary outcome is the between-group difference in the reclassification rate of the initial diagnosis based on invasive angiography versus the final diagnosis after CMR imaging. Randomized, controlled trial: Participants will be randomized to inclusion (intervention group) or exclusion (control group) of myocardial blood flow to inform the final diagnosis. The primary outcome of the clinical trial is the mean within-subject change in the Seattle Angina Questionnaire summary score (SAQSS) at 6 months. Secondary outcome assessments include the EUROQOL EQ-5D-5L questionnaire, the Brief Illness Perception Questionnaire (Brief-IPQ), the Treatment Satisfaction Questionnaire (TSQM-9), the Patient Health Questionnaire-4 (PHQ-4), the Duke Activity Status Index (DASI), the International Physical Activity Questionnaire- Short Form (IPAQ-SF), the Montreal Cognitive Assessment (MOCA) and the 8-item Productivity Cost Questionnaire (iPCQ). Health and economic outcomes will be assessed using electronic healthcare records. Value: To clarify if routine stress perfusion CMR imaging reclassifies the final diagnosis in patients with ANOCA and whether this strategy improves symptoms, health-related quality of life and health economic outcomes. NCT04805814

Item Type:Articles
Status:In Press
Glasgow Author(s) Enlighten ID:Berry, Professor Colin and McConnachie, Professor Alex and Good, Dr Richard and Heggie, Mr Robert and Eteiba, Professor Hany and Orchard, Miss Vanessa and Corcoran, Dr David and McKinley, Miss Gemma and Wu, Professor Olivia and Watkins, Dr Stuart and Bradley, Dr Conor
Authors: Bradley, C. P., Orchard, V., McKinley, G., Heggie, R., Wu, O., Good, R., Watkins, S., Lindsay, M., Eteiba, H., McGowan, J., McGeoch, R., Corcoran, D., Kellman, P., McConnachie, A., and Berry, C.
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Health Economics and Health Technology Assessment
College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
Journal Name:American Heart Journal
ISSN (Online):1097-6744
Published Online:30 August 2023
Copyright Holders:Copyright © 2023 Elsevier Inc.
First Published:First published in American Heart Journal 2023
Publisher Policy:Reproduced in accordance with the publisher copyright policy

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
306138The clinical utility of cardiac magnetic resonance imaging in patients with angina but no obstructive coronary disease: an observational study and nested clinicalColin BerryBritish Heart Foundation (BHF)PG/19/28/34310SCMH - Cardiovascular & Metabolic Health
303944BHF Centre of ExcellenceColin BerryBritish Heart Foundation (BHF)RE/18/6/34217SCMH - Cardiovascular & Metabolic Health