MAGNESIUM IN CORONARIES

冠状动脉中的镁

• 批准号: 6056786
• 负责人: SONJA M MCKINLAY
• 金额: $ 194.16万
• 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/6056786
• 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早期治疗是否与 静脉注射镁可降低高危人群的短期死亡率 疑似急性心肌梗死患者(表现为ST 心电图上的抬高)。治疗应及早进行。 以减少再灌流损伤。主要终结点将是全因30 天数死亡率。明确镁的益处机制 治疗和评估次要终点镁的耐受性 将包括心源性休克、心室性休克的发展 纤颤、充血性心力衰竭和传导延迟 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， 安慰剂对照的双盲试验，将随机分为 10,400名疑似急性心肌梗死患者。患者 不接受溶栓治疗或接受初次血管成形术(PTCA) 如果他们能在6小时内开始注射镁，则随机进行 症状的出现。大于或等于65岁的病人 接受再通治疗(使用溶栓剂或PTCA)将是 符合条件的镁可以在服用之前或同时服用 作为再灌注治疗。患者将按随机分组 根据他们是否接受再灌注。研究详情 设计，包括进入标准、随机程序和分析 它将被纳入议定书中，将通过指导制定 该委员会将包括新英格兰研究院。