University Hospital of Mulhouse, Hôpital Emile Muller, Mulhouse, France.
Cardiology Department, PhyMedExp, INSERM, CNRS, CHU de Montpellier, Université de Montpellier, Montpellier, France.
Cardiology. 2021;146(2):151-160. doi: 10.1159/000512772. Epub 2021 Feb 12.
Inflammatory processes have been identified as key mediators of ischemia-reperfusion injury in ST-segment elevation myocardial infarction (STEMI). They add damage to the myocardium and are associated with clinical adverse events (heart failure and cardiovascular death) and poor myocardial recovery. Colchicine is a well-known alkaloid with potent anti-inflammatory properties. In a proof-of-concept phase II trial, colchicine has been associated with a significant 50% reduction of infarct size (assessed by creatine kinase levels) in comparison to placebo in acute STEMI patients referred for primary percutaneous coronary intervention (PPCI). The Colchicine in STEMI Patients Study (COVERT-MI) is an ongoing confirmative prospective, multicenter, randomized, double-blind trial testing whether a short course oral treatment with colchicine versus placebo decreases myocardial injury in patients presenting with STEMI referred for PPCI. Adult patients, with a first STEMI episode and an initial TIMI flow ≤1, referred for PPCI, will be randomized (n = 194) in a 1:1 ratio to receive an oral bolus of colchicine of 2 mg followed by 0.5 mg b.i.d. treatment during 5 days or matching placebo. The primary endpoint will be the reduction in infarct size as assessed by cardiac magnetic resonance at 5 ± 2 days between both groups. The main secondary endpoints will be tested between groups in hierarchical order with left ventricular ejection fraction at 5 days, microvascular obstruction presence at 5 days, and absolute adverse left ventricular remodeling between 5 days and 3 months. This academic study is being financed by a grant from the French Ministry of Health (PHRCN-16-0357). Results from this study will contribute to a better understanding of the complex pathophysiology underlying myocardial injury after STEMI. The present study describes the rationale, design, and methods of the trial.
炎症过程已被确定为 ST 段抬高型心肌梗死（STEMI）中缺血再灌注损伤的关键介质。它们会对心肌造成损伤，并与临床不良事件（心力衰竭和心血管死亡）和心肌恢复不良相关。秋水仙碱是一种具有强大抗炎特性的著名生物碱。在一项概念验证的 II 期试验中，与安慰剂相比，秋水仙碱在接受直接经皮冠状动脉介入治疗（PPCI）的急性 STEMI 患者中可使梗死面积显著减少 50%（通过肌酸激酶水平评估）。COVERT-MI 研究是一项正在进行的确认性前瞻性、多中心、随机、双盲试验，旨在测试短疗程口服秋水仙碱与安慰剂相比是否能减少接受 PPCI 的 STEMI 患者的心肌损伤。患有首次 STEMI 发作且初始 TIMI 血流≤1 的成年患者将被随机（n = 194）分为 1:1 组，分别接受 2 mg 口服秋水仙碱冲击剂量，随后在 5 天内每天接受 0.5 mg 秋水仙碱治疗或匹配的安慰剂。主要终点是两组之间通过心脏磁共振在 5 ± 2 天评估的梗死面积减少。主要次要终点将按层次顺序在两组之间进行测试，包括 5 天的左心室射血分数、5 天的微血管阻塞存在情况以及 5 天至 3 个月之间的绝对不良左心室重构。这项学术研究由法国卫生部（PHRCN-16-0357）资助。该研究的结果将有助于更好地理解 STEMI 后心肌损伤的复杂病理生理学。本研究描述了试验的原理、设计和方法。
