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评估短暂性ST段抬高型心肌梗死患者血运重建的最佳时机:TRANSIENT试验的原理与设计

Evaluating the optimal timing of revascularisation in patients with transient ST-segment elevation myocardial infarction: rationale and design of the TRANSIENT Trial.

作者信息

Lemkes Jorrit, Nijveldt Robin, Beek Aernout M, Knaapen Paul, Hirsch Alexander, Meijers Joost, Allaart Cor P, van Rossum Albert, van Royen Niels

机构信息

Department of Cardiology, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands,

出版信息

J Cardiovasc Transl Res. 2014 Aug;7(6):590-6. doi: 10.1007/s12265-014-9572-6. Epub 2014 May 30.

Abstract

Patients with chest pain and a prehospital ST-segment elevation myocardial infarction (STEMI) are preferably treated with immediate percutaneous coronary intervention (PCI). However, patients with normalization of symptoms and ST-segment elevation upon hospital arrival (transient STEMI) received inconsistent therapy due to logistic reasons and the absence of evidence or explicit guidelines. In this trial, the optimal timing of coronary angiography and subsequent revascularisation is investigated in patients presenting with transient STEMI. In this prospective, multicentre, randomized controlled clinical trial, 142 consecutive patients with initially acute chest pain and STEMI, whose symptoms and ST-segment elevation resolve upon admission, are randomized to immediate intervention or a delayed intervention. Primary outcome is infarct size measured at 4 days determined by cardiovascular magnetic resonance. Secondary outcomes are left ventricular function and volumes, myocardial salvage and microvascular injury at baseline; the change in left ventricular function, volumes and infarct size at 4 months; and major adverse cardiac events at 4 and 12 months. The TRANSIENT Trial evaluates whether a delayed invasive strategy (according to NSTEMI-guidelines) is superior to an immediate invasive strategy (according to STEMI-guidelines) in patients with a transient STEMI.

摘要

胸痛且伴有院前ST段抬高型心肌梗死(STEMI)的患者最好接受直接经皮冠状动脉介入治疗(PCI)。然而,因后勤原因以及缺乏证据或明确指南,症状和ST段抬高在入院时已恢复正常的患者(短暂性STEMI)接受的治疗并不一致。在本试验中,对出现短暂性STEMI的患者冠状动脉造影及后续血运重建的最佳时机进行了研究。在这项前瞻性、多中心、随机对照临床试验中,142例最初有急性胸痛和STEMI且入院时症状和ST段抬高已缓解的连续患者被随机分为立即干预组或延迟干预组。主要结局是通过心血管磁共振测定的第4天梗死面积。次要结局包括基线时的左心室功能和容积、心肌挽救和微血管损伤;第4个月时左心室功能、容积和梗死面积的变化;以及第4个月和12个月时的主要不良心脏事件。“短暂性(TRANSIENT)试验”评估了在短暂性STEMI患者中,延迟侵入性策略(根据非ST段抬高型心肌梗死指南)是否优于立即侵入性策略(根据ST段抬高型心肌梗死指南)。

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