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HEAR 和 HEART 评分对急诊科胸痛患者排除主要不良心脏事件的疗效:eCARE 逐步随机对照试验研究方案。

Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial.

机构信息

Département de Médecine d'Urgence, CHU d'Angers, Angers, France

Institut MitoVasc, UMR CNRS 6215 INSERM 1083, Université d'Angers, Angers, France.

出版信息

BMJ Open. 2022 Dec 6;12(12):e066953. doi: 10.1136/bmjopen-2022-066953.

Abstract

INTRODUCTION

Current guidelines for patients presenting to the emergency department (ED) with chest pain without ST-segment elevation myocardial infarction (STEMI) on ECG are based on serial troponin measurements. A clinical tool able to identify very low-risk patients who could forgo a troponin test and low-risk patients requiring only one troponin measurement would be of great interest. To do so, the HEAR and HEART score, standing for history, ECG, age, risk factors±troponin were prospectively assessed, but not combined and implemented in clinical practice. The objective of the eCARE study is to assess the impact of implementing a diagnostic strategy based on a HEAR score <2 or a HEART score <4 (HEAR-T strategy) to rule out non-STEMI without or with a single troponin measurement in patients presenting to the ED with chest pain without obvious diagnosis after physical examination and an ECG.

METHODS AND ANALYSIS

Stepped-wedge cluster-randomised control trial in 10 EDs. Patients with non-traumatic chest pain and no formal diagnosis were included and followed for 30 days. In the interventional phase, the doctor will be asked not to perform a troponin test to look for an acute coronary if the HEAR score is <2 and not to perform an additional troponin test if the HEAR score is ≥2 and HEART score is <4. The main endpoint is the non-inferiority of the rates of major adverse cardiac events occurring between a patient's discharge and the 30-day follow-up against current recommended guidelines.

ETHICS AND DISSEMINATION

The study was approved by an institutional review board for all participating centres. If successful, the eCARE study will cover a gap in the evidence, proving that it is safe and efficient to rule out the hypothesis of an acute myocardial infarction in some selected very low-risk patients or based on a single troponin measurement in some low-risk patients.

TRIAL REGISTRATION NUMBER

NCT04157790.

摘要

简介

目前,对于心电图无 ST 段抬高心肌梗死(STEMI)的胸痛患者,急诊科(ED)的处理指南基于连续肌钙蛋白测量。如果有一种临床工具能够识别出极低危患者,使其无需进行肌钙蛋白检测,或仅需进行一次肌钙蛋白测量就能识别出低危患者,将具有重要意义。为此,前瞻性评估了 HEAR(代表病史、心电图、年龄、危险因素±肌钙蛋白)和 HEART(代表病史、心电图、年龄、危险因素、充血性心力衰竭、血管疾病、年龄、肌酐、troponin)评分,但并未将两者组合并应用于临床实践。eCARE 研究的目的是评估基于 HEAR 评分<2 或 HEART 评分<4(HEAR-T 策略)排除无明显诊断的 ED 胸痛患者非 ST 段抬高型心肌梗死(NSTEMI)的诊断策略,不进行或仅进行一次肌钙蛋白检测。

方法和分析

这是一项在 10 家 ED 进行的阶梯式楔形集群随机对照试验。纳入非创伤性胸痛且体检和心电图无明确诊断的患者,并进行 30 天随访。在干预阶段,如果 HEAR 评分<2,医生将被要求不进行肌钙蛋白检测以寻找急性冠状动脉疾病;如果 HEAR 评分≥2 且 HEART 评分<4,则医生将被要求不进行额外的肌钙蛋白检测。主要终点是在患者出院至 30 天随访期间,主要不良心脏事件发生率不劣于当前推荐指南。

伦理和传播

该研究得到了所有参与中心的机构审查委员会的批准。如果成功,eCARE 研究将填补证据空白,证明在某些特定的极低危患者中,或在某些低危患者中基于单次肌钙蛋白测量排除急性心肌梗死假说,是安全且有效的。

试验注册号

NCT04157790。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df11/9730388/b2d493d4f31e/bmjopen-2022-066953f01.jpg

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