THROMBOLYSIS IN MI (TIMI) II FOLLOW-UP

心肌梗死溶栓（TIMI）II期研究是 旨在确定静脉溶栓治疗是否 在急性心肌梗死的早期给予， 随后经皮腔内冠状动脉成形术 （PTCA）。 所有患者均接受重组组织治疗 纤溶酶原激活剂（rt-PA）在发病后4小时内 急性心肌梗死的症状 TIMI组 临床中心的患者随机接受rt-PA单药治疗或一种 两组的PTCA手术时间分别为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单药治疗或rt-PA治疗 再加上18到48小时的经皮冠状动脉成形术 此外，在这些临床 中心所有符合启动β- 阻滞剂治疗随机分为立即或延迟 β受体阻滞剂治疗 II期患者招募开始于 1986年4月至1987年9月30日，共有2,351名患者 被录取了 招募目标是4,000名患者， 1988年6月底。 除协调中心外的所有中心的当前资金 和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1989年9月30日结束 凝血核心实验室的资金将于 一九九一年九月三十日 可用的临床中心资金将 为患者提供随访至1988年8月， 患者将被随访六周，但只有一半的患者 患者将完成一年的随访检查 议定书中规定的。 本申请的目的是 获得支持，以（1）完成 所有入组患者的TIMI II方案，电话 在三个月和六个月时进行接触， 1年时进行平板运动试验;（2）维持年度随访 所有患者至少三年;（3）继续 TIMI研究者在使用大量TIMI数据方面的活动 银行准备研究报告以供发表;以及（4）提供 协助TIMI研究者分析辅助 问题研究

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.