THROMBOLYSIS IN MI (TIMI) II FOLLOW-UP

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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.