THROMBOLYSIS IN MYOCARDIAL ISCHEMIA COORDINATING CENTER

心肌缺血协调中心的溶栓

• 批准号: 3360643
• 负责人: Genell L Knatterud
• 金额: $ 57.7万
• 依托单位: MARYLAND MEDICAL RESEARCH INSTITUTE, INC
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-07-01 至 1993-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3360643
• 关键词: angina pectoris; angiocardiography; angiography; cardiovascular stress test; clinical trials; combination chemotherapy; drug administration rate /duration; electrocardiographic monitor; fibrinolysis; fibrinolytic therapy; heart catheterization; heart disorder; heparin; human subject; human therapy evaluation; intraluminal angioplasty; myocardial infarction; plasminogen activator

The Thrombolysis in Myocardial Ischemia (TIMI III) studies consist of two multicenter, randomized controlled clinical trials in patients with unstable angina or non-Q-wave myocardial infarction. TIMI III A is a double-blind comparison of recombinant tissue plasminogen activator (t-PA) to placebo for improvement of coronary artery stenosis and perfusion. TIMI III B will compare, in a 2x2x2 factorial design, double-blind treatment with t-PA or placebo, known treatment with or without heparin, and management with or without cardia catheterization (and percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery, if appropriate) at 24-48 hours after presentation for the prevention of death, subsequent myocardial infarction, disabling stroke or treatment failure as defined by the results of ambulatory ECG monitoring, exercise testing and clinical observations. After three months of planning and study start up, TIMI III A Investigators will start recruitment to achieve a goal of 300 patients in nine months; and TIMI III B Investigators will start recruitment to achieve a goal of 2,000 patients in 24 months. Upon completion of TIMI III A recruitment, TIMI III A Clinical Centers may participate in the TIMI III B Protocol. The last year of this four-year project will be dedicated to data analysis and preparation of presentations and publications. This application is to support the Coordinating Center at the Maryland Medical Research Institute. The Coordinating Center will be responsible for treatment assignments, supervision of the Drug Distribution Center, monitoring Core Laboratories, direction of an Adverse Events Classification Committee, rapid communication and generation of performance data for review with the Principal Investigator's Office, and data analysis to assess treatment and management strategy effects. An independent Safety and Data Monitoring Committee, appointed by the National Heart, Lung and Blood Institute (NHLBI), will meet at regular intervals to review both performance data and treatment results to advise the TIMI III Investigators and NHLBI leadership on the conduct of the study.

心肌缺血中的溶栓治疗(TIMI III)研究包括两项 慢性阻塞性肺疾病患者的多中心随机对照临床试验 不稳定型心绞痛或非Q波型心肌梗死。TIMI III A是一款 重组组织型纤溶酶原激活剂(t-PA)的双盲对照 以安慰剂改善冠状动脉狭窄程度和血流灌注率。TIMI III B将在2x2x2析因设计中比较双盲处理 使用t-PA或安慰剂，已知的使用或不使用肝素的治疗，以及 应用或不使用心导管(和经皮心导管)的治疗 腔内冠状动脉成形术或冠状动脉搭桥术， 如果适当)在提交后24-48小时，以防止 死亡、继发性心肌梗死、致残性中风或治疗 由动态心电监测、运动结果定义的失败 检测和临床观察。经过三个月的计划和 研究启动，TIMI III A调查员将开始招募，以实现 9个月内300名患者的目标；TIMI III B调查人员将 开始招募，以实现24个月内2,000名患者的目标。vt.在.的基础上 TIMI III A招聘完成，TIMI III A临床中心可能 参与TIMI III B议定书。这四年的最后一年 项目将致力于数据分析和演示文稿的准备 和出版物。 此应用程序用于支持马里兰州的协调中心 医学研究所。协调中心将负责 治疗任务，药品配送中心的监督， 监测核心实验室，不良事件分类的方向 委员会，快速沟通和生成业绩数据 与首席调查员办公室进行审查，并进行数据分析，以 评估治疗和管理策略的效果。独立的安全 和数据监测委员会，由国家心肺和卫生局任命 血液研究所(NHLBI)将定期举行会议，审查这两个 性能数据和治疗结果，为TIMI III调查人员提供建议 以及NHLBI领导对该研究的进行。