MAGNESIUM IN CORONARIES

冠状动脉中的镁

• 批准号: 6133114
• 负责人: SONJA M MCKINLAY
• 金额: $ 4.7万
• 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 2001-04-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6133114
• 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 静脉注射镁将降低高风险的短期死亡率 怀疑急性心肌梗塞的患者（呈现ST 心电图上的高程）。治疗将得到足够的早期治疗 减少再灌注损伤。主要终点将是全原因30 天死亡率。定义镁受益机制 处理和评估镁，次要终点的耐受性 将包括心源性休克的发展，心室 纤颤，充血性心力衰竭和需要的传导延迟 临时起搏器的放置。 为了实现这一目标，承包商将进行多中心， 安慰剂对照，双盲试验将大约随机进行 10,400例怀疑急性心肌梗塞的患者。患者 请勿接受溶栓疗法或原发性血管成形术（PTCA） 随机分组是否可以在6小时内开始镁输注 症状的发作。大于或等于65岁的患者 接受再灌注疗法（具有溶栓或PTCA）将是 符合条件提供的镁可以在同一时间之前或同时管理 作为再灌注疗法。患者将随机分层 根据他们是否接受再灌注。研究的细节 设计，包括进入标准，随机程序和分析 该协议将通过转向开发 将包括新英格兰研究机构的委员会。