Department of Cardiovascular Sciences, Glenfield Hospital, Leicester, UK
Department of Cardiovascular Sciences, Glenfield Hospital, Leicester, UK.
BMJ Open. 2022 May 3;12(5):e055878. doi: 10.1136/bmjopen-2021-055878.
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.
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.
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.
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.
NCT03707314; Pre-results.
对于非 ST 段抬高型心肌梗死（NSTEMI）高危患者，侵入性冠状动脉造影（ICA）的最佳时机缺乏随机数据。国际指南推荐早期行 ICA 主要基于中性试验的回顾性亚组分析。
RAPID NSTEMI 试验旨在确定与标准护理策略相比，高危 NSTEMI 患者行非常早期经皮血运重建是否能改善临床结局。
RAPID NSTEMI 是一项前瞻性、多中心、开放标签、随机对照、实用策略试验。高风险 NSTEMI 患者，定义为全球急性冠状动脉事件登记 2.0 评分≥118，或≥90 分且至少有一个额外高危特征，被随机分配至：非常早期 ICA±血运重建或标准 ICA±血运重建的时机。主要结局为 12 个月时至少有以下一项事件（全因死亡率、非致死性心肌梗死和心力衰竭再入院）的患者比例。关键次要结局包括大出血和卒中等。假设产生的心脏磁共振（CMR）子研究将提供经皮冠状动脉介入治疗后梗死面积、心肌挽救和残留缺血的机制数据。2021 年 4 月 7 日，由于 COVID-19 大流行的影响和低于预期的事件发生率，赞助商停止了入组。共纳入 425 例患者，其中 61 例行 CMR。
该试验已在东英格兰剑桥东部研究伦理委员会（18/EE/0222）进行了审查和批准。研究结果将在完成后 6 个月内提交发表。
NCT03707314；预结果。
