THROMBOLYSIS IN MYOCARDIAL ISCHEMIA COORDINATING CENTER

心肌缺血协调中心的溶栓

• 批准号: 3360645
• 负责人: Genell L Knatterud
• 金额: $ 32.9万
• 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 1994-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3360645
• 关键词: angina pectoris; angiocardiography; angiography; biological products; cardiovascular stress test; clinical trials; combination chemotherapy; drug administration rate /duration; electrocardiographic monitor; fibrinolysis; fibrinolytic therapy; genetic manipulation; 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.

心肌缺血溶栓（TIMI III）研究包括两项 多中心、随机对照临床试验 不稳定型心绞痛或非Q波心肌梗死。 TIMI III A是一种 重组组织型纤溶酶原激活剂（t-PA）双盲比较 与安慰剂相比，用于改善冠状动脉狭窄和灌注。 Timi III B将在2x2x2析因设计中比较双盲治疗 使用t-PA或安慰剂，已知使用或不使用肝素治疗，以及 有或无贲门导管插入术（和经皮 经腔冠状动脉成形术或冠状动脉旁路移植手术， 如果合适的话）在出现后24 - 48小时， 死亡、后续心肌梗死、致残性卒中或治疗 根据动态ECG监测结果定义的失败，运动 测试和临床观察。 经过三个月的规划， 研究启动时，TIMI III A研究者将开始招募， 9个月内300例患者的目标; TIMI III B研究者将 开始招募，以实现在24个月内招募2,000名患者的目标。 后 完成TIMI III A招募后，TIMI III A临床中心可 参与TIMI III B方案。 这四年的最后一年 该项目将致力于数据分析和演示文稿的准备 和出版物。 此应用程序是为了支持协调中心在马里兰州 医学研究所。 协调中心将负责 用于治疗分配，监督药物配送中心， 监测核心实验室，不良事件分类指导 快速沟通和生成业绩数据， 与主要研究者办公室进行审查，并进行数据分析， 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，由国家心脏，肺和 血液研究所（NHLBI）将定期开会， 向TIMI III研究者提供建议的性能数据和治疗结果 和NHLBI领导对研究的进行。