THROMBOLYSIS IN MYOCARDIAL INFARCTION

心肌梗塞中的血栓溶解

基本信息

批准号：
3661342
负责人：
GERALD C TIMMIS
金额：
$ 3.2万
依托单位：
WILLIAM BEAUMONT HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
1986
资助国家：
美国
起止时间：
1986-03-01 至 1988-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/3661342
关键词：
cardiotonic agents cooperative study coronary vasodilator drug administration routes drug adverse effect fibrinolytic agents fibrinolytic therapy heart disorder diagnosis heart imaging /visualization /scanning heart motion human subject human therapy evaluation intracardiac volume myocardial infarct sizing myocardial infarction nitroglycerin radionuclide diagnosis

项目摘要

The Thrombolysis in Myocardial Infarction (TIMI) Phase II Trial is designed to determine whether intravenous thrombolytic therapy given in the early hours of an acute myocardial infarction should be followed by elective percutaneous transluminal coronary angioplasty (PTCA). All patients will be treated with recombinant tissue-type plasminogen activator (rt-PA) within four hours of the onset of symptoms of an acute myocardial infarction. In one group of TIMI Clinical Centers, patients will be randomized to rt-PA alone or to rt-PA followed by elective angioplasty which will be performed either at three hours after the start of the infusion of rt-PA or at 18 to 36 hours after the start of the infusion of rt-PA. In all other TIMI Clinical Centers, patients will be randomized to rt-PA alone or rt-PA plus 18 to 36 hours PTCA. In addition, in these latter clinics, all patients who are eligible for the initiation of beta-blocker therapy will be randomized to either immediate or deferred beta-blocker therapy. The primary objective of TIMI Phase II is to determine the effects of thrombolytic therapy alone versus thrombolytic therapy followed within 18 to 36 hours by elective PTCA. The principal endpoint for this comparison is the combined endpoint total mortality and nonfatal myocardial infarction at three months after an acute myocardial infarction. Secondary objectives include the assessment of the combination endpoint at one-year follow-up, and at 10 days post infarction (in-hospital mortality and infarction).

心肌梗塞溶栓 (TIMI) II 期试验的设计以确定是否在早期给予静脉溶栓治疗急性心肌梗塞发生后数小时内应进行选择性治疗经皮冠状动脉腔内成形术（PTCA）。所有患者都会用重组组织型纤溶酶原激活剂（rt-PA）治疗急性心肌病症状出现后四小时内梗塞。在一组 TIMI 临床中心中，患者将随机接受单独 rt-PA 治疗或先接受 rt-PA 治疗后选择性血管成形术这将在比赛开始后三小时进行输注 rt-PA 或开始输注后 18 至 36 小时 rt-PA。在所有其他 TIMI 临床中心，患者将被随机分配到单独 rt-PA 或 rt-PA 加 18 至 36 小时 PTCA。此外，在这些后者诊所，所有有资格开始接受治疗的患者 β-受体阻滞剂治疗将随机分为立即治疗或延迟治疗 β-受体阻滞剂治疗。 TIMI II 期的主要目标是确定单独溶栓治疗与溶栓治疗的效果 18 至 36 小时内进行选择性 PTCA 治疗。校长该比较的终点是综合终点总死亡率和急性心肌梗死后三个月内发生非致命性心肌梗塞梗塞。次要目标包括评估组合终点为一年随访时和梗死后 10 天（院内）死亡率和梗死）。