MAGNESIUM IN CORONARIES

这项拟议的研究将确定早期治疗是否 静脉注射镁将降低高危人群的短期死亡率 疑似急性心肌梗塞患者（表现为 ST 心电图上的海拔）。治疗将尽早进行 以减少再灌注损伤。主要终点为全因 30 天死亡率。定义镁的益处机制 治疗和评估镁的耐受性，次要终点 将包括心源性休克、心室性休克的发展 颤动、充血性心力衰竭和传导延迟需要 放置临时起搏器。 为了实现这一目标，承包商将进行多中心、 安慰剂对照、双盲试验将随机大约 10,400 名疑似急性心肌梗死患者。患者谁 不接受溶栓治疗或初次血管成形术 (PTCA) 如果他们可以在 6 小时内开始镁输注，则进行随机分组 症状出现。年龄大于或等于65岁的患者 接受再灌注治疗（溶栓剂或 PTCA）将 符合条件的条件是镁可以在之前或同时服用 作为再灌注治疗。患者将被随机分层 基于他们是否接受再灌注。研究详情 设计，包括进入标准、随机化程序和分析 它将被纳入协议中，并将由指导委员会开发 委员会将包括新英格兰研究所。

This proposed study will determine whether early treatment with intravenous magnesium will reduce short-term mortality of high risk patients with suspected acute myocardial infarction (presenting with ST elevation on the ECG). Treatment will be administered sufficiently early to reduce reperfusion injury. The primary endpoint will be all-cause 30 days mortality. To define the mechanisms of benefit from magnesium treatment and assess the tolerableness of magnesium, secondary endpoint will include the development of cardiogenic shock, ventricular fibrillation, congestive heart failure, and conduction delay that requires the placement of a temporary pacemaker. To accomplish this objective, the contractor will conduct a multicenter, placebo-controlled, double blind trial that will randomize approximately 10,400 patients with suspected acute myocardial infarction. Patients who do not receive thrombolytic therapy or primary angioplasty (PTCA) will be randomized if they can begin their magnesium infusion within 6 hours of the onset of symptoms. Patients greater than or equal to 65 years of age undergoing reperfusion therapy (either with thrombolytics or PTCA) will be eligible provided magnesium can be administered before or at the same time as the reperfusion therapy. Patients will be stratified at randomization based on whether or not they receive reperfusion. Details of the study design, including entry criteria, randomization procedures, and analyses which will be incorporated in the protocol will be developed by a Steering Committee that will include the New England Research Institutes.