Département de Médecine d'Urgence, CHU d'Angers, Angers, France
Institut MitoVasc, UMR CNRS 6215 INSERM 1083, Université d'Angers, Angers, France.
BMJ Open. 2022 Dec 6;12(12):e066953. doi: 10.1136/bmjopen-2022-066953.
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.
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.
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.
NCT04157790.
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。
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。
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。
NCT04157790。
