Kite, T. A. et al. (2022) Very early invasive angiography versus standard of care in higher-risk non-ST elevation myocardial infarction: study protocol for the prospective multicentre randomised controlled RAPID N-STEMI trial. BMJ Open, 12(5), e055878. (doi: 10.1136/bmjopen-2021-055878) (PMID:35504645) (PMCID:PMC9066091)
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Abstract
Background: There are a paucity of randomised data on the optimal timing of invasive coronary angiography (ICA) in higher-risk patients with non-ST elevation myocardial infarction (N-STEMI). International guideline recommendations for early ICA are primarily based on retrospective subgroup analyses of neutral trials. Aims: The RAPID N-STEMI trial aims to determine whether very early percutaneous revascularisation improves clinical outcomes as compared with a standard of care strategy in higher-risk N-STEMI patients. Methods and analysis: RAPID N-STEMI is a prospective, multicentre, open-label, randomised-controlled, pragmatic strategy trial. Higher-risk N-STEMI patients, as defined by Global Registry of Acute Coronary Events 2.0 score ≥118, or >90 with at least one additional high-risk feature, were randomised to either: very early ICA±revascularisation or standard of care timing of ICA±revascularisation. The primary outcome is the proportion of participants with at least one of the following events (all-cause mortality, non-fatal myocardial infarction and hospital admission for heart failure) at 12 months. Key secondary outcomes include major bleeding and stroke. A hypothesis generating cardiac magnetic resonance (CMR) substudy will provide mechanistic data on infarct size, myocardial salvage and residual ischaemia post percutaneous coronary intervention. On 7 April 2021, the sponsor discontinued enrolment due to the impact of the COVID-19 pandemic and lower than expected event rates. 425 patients were enrolled, and 61 patients underwent CMR. Ethics and dissemination: The trial has been reviewed and approved by the East of England Cambridge East Research Ethics Committee (18/EE/0222). The study results will be submitted for publication within 6 months of completion. Trial registration number: NCT03707314; Pre-results.
Item Type: | Articles |
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Additional Information: | The study is funded by the British Heart Foundation (grant number: CS/17/1/32445). |
Status: | Published |
Refereed: | Yes |
Glasgow Author(s) Enlighten ID: | Berry, Professor Colin |
Authors: | Kite, T. A., Banning, A. S., Ladwiniec, A., Gale, C. P., Greenwood, J. P., Dalby, M., Hobson, R., Barber, S., Parker, E., Berry, C., Flather, M. D., Curzen, N., Banning, A. P., McCann, G. P., and Gershlick, A. H. |
College/School: | College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health |
Journal Name: | BMJ Open |
Publisher: | BMJ Publishing Group |
ISSN: | 2044-6055 |
ISSN (Online): | 2044-6055 |
Published Online: | 03 May 2022 |
Copyright Holders: | Copyright © 2022 The Authors |
First Published: | First published in BMJ Open 12(5): e055878 |
Publisher Policy: | Reproduced under a Creative Commons License |
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