THROMBOLYSIS IN MI (TIMI) II FOLLOW-UP

心肌梗死溶栓治疗(TIMI)II期研究 旨在确定静脉溶栓治疗是否 在急性心肌梗死的早期给药应该是 随后是经皮冠状动脉腔内成形术 (PTCA)。所有患者均接受重组组织治疗。 纤溶酶原激活物(rt-PA)在发病后4小时内 急性心肌梗塞的症状。在一组TIMI中 临床中心的患者被随机分为单独使用rt-PA或使用rt-PA 两组接受PTCA的时间分别为2小时或18小时 至rt-PA输注开始后48小时。在所有其他TIMI中 临床中心患者随机接受rt-PA单独治疗或rt-PA治疗 外加18至48小时的PTCA。此外，在这些后一种临床 中心所有有资格启动贝塔试验的患者- 阻滞剂治疗被随机分为立即治疗或延期治疗 β-受体阻滞剂疗法。第二阶段开始招募病人 1986年4月，截至1987年9月30日，共有2351名患者 已经被录取了。招募目标是到2010年招募4000名患者 1988年6月底。 除协调中心外，所有中心的当前资金 凝血核心实验室将于1988年9月30日结束。 协调中心的资金将于9月30日结束， 为凝聚核心实验室提供的资金将于#年结束 1991年9月30日。临床中心的可用资金将 为患者提供到1988年8月的随访，以便所有 患者将接受六周的随访，但只有一半的患者 患者将完成一年的随访检查 在议定书中规定的。此应用程序的目的是 获得支持以(1)完成一年跟踪，如中所述 TIMI II协议适用于所有登记的患者，并提供电话 三个月和六个月的接触和检查，包括 一年的跑步机运动试验；(2)保持年度随访 最少三年；(3)继续 TIMI调查人员在使用大量TIMI数据时的活动 银行须拟备研究报告以供发表；及。(四)提供 协助TIMI调查人员分析辅助性 学习。

The Thrombolysis in Myocardial Infarction (TIMI) Phase II study is designed to determine whether intravenous thrombolytic therapy given in the early hours of acute myocardial infarction should be followed by percutaneous transluminal coronary angioplasty (PTCA). All patients are treated with recombinant tissue plasminogen activator (rt-PA) within four hours of the onset of symptoms of acute myocardial infarction. In one group of TIMI Clinical Centers patients are randomized to rt-PA alone or to one of two groups with PTCA to be performed either two hours or 18 to 48 hours after the start of the rt-PA infusion. In all other TIMI Clinical Centers patients are randomized to rt-PA alone or rt-PA plus 18 to 48-hour PTCA. In addition in these latter Clinical Centers all patients who are eligible for the initiatin of beta- blocker therapy are randomized to either immediate or deferred beta-blocker therapy. Patient recruitment for Phase II started in April 1986 and as of September 30, 1987 a total of 2,351 patients had been enrolled. The recruitment goal is 4,000 patients by the end of June 1988. Current funding for all centers except the Coordination Center and Coagulation Core laboratory will end September 30, 1988. Funding for the Coordinating Center will end September 30, 1989 and funding for the coagulation Core Laboratory will end in September 30, 1991. The available Clinical Center funds will provide for patient follow-up through August 1988 so that all patients will be followed through six weeks but only half of the patients will have completed the one year follow-up examination specified in the Protocol. The purpose of this application is to obtain support to (1) complete one year follow-up as outlined in the TIMI II Protocol on all patients enrolled, with telephone contacts at three and six months and an examination including treadmill exercise test at one year; (2) maintain annual follow-up of all patients for a minimum of three years; (3) continue the activity of the TIMI investigators in using the extensive TIMI data bank to prepare study reports for publication; and (4) provide assistance to TIMI investigators in the analysis of ancillary studies.