MAGNESIUM IN CORONARIES

冠状动脉中的镁

• 批准号: 6320757
• 负责人: SONJA M MCKINLAY
• 金额: $ 124.27万
• 依托单位: NEW ENGLAND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-04-15 至 2002-03-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6320757
• 关键词: cardiovascular disorder chemotherapy; clinical research; disease /disorder onset; drug screening /evaluation; human subject; human therapy evaluation; magnesium ion; myocardial infarction

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.

这项拟议的研究将确定是否早期治疗与 静脉注射镁可降低高危患者的短期死亡率 疑似急性心肌梗死患者（表现为ST 在ECG上升高）。治疗将尽早进行 以减少再灌注损伤。主要终点为全因30 死亡天数。明确镁的作用机制 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 纤维性颤动、充血性心力衰竭和传导延迟， 临时起搏器的植入 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， 10,400例疑似急性心肌梗死患者。的患者 不接受溶栓治疗或直接血管成形术（PTCA）将 如果患者能够在术后6小时内开始镁输注，则将其随机分组 症状的发作。年龄≥ 65岁的患者 接受再灌注治疗（溶栓剂或PTCA）的患者将 合格的镁可在给药前或同时给药 再灌注疗法。患者将在随机化时分层 根据他们是否接受再灌注。研究的详细情况 设计，包括入选标准、随机化程序和分析 将由指导委员会制定， 委员会将包括新英格兰研究所。