CONTINUED UTILIZATION OF THE MILIS DATA BASE

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The proposed application is for continued support for analysis of the Multicenter Investigation of the Limitation of Infarct Size (MILIS) data base. The MILIS trial was a collaborative, randomized, controlled study testing the efficacy of hyaluronidase and propranolol in the early treatment of acute myocardial infarction. A total of 9,450 patients were screened for the trial and 985 patients were randomized at five major hospitals. Follow-up ended on July 1, 1984 with a mean follow-up time of 31.8 months. The trial involved extensive clinical and laboratory monitoring evaluations collected under a standard protocol during the acute event including routine laboratory test data, baseline histories, serial blood sampling for enzymes, technetium-99m pyrophosphate myocardial scintigraphy, multigated radionuclide ventriculography, standard 12-lead ECGs, precordial ECG mapping, vectorcardiograms and 24-hour Holter recordings. In addition, follow-up visits were scheduled for all patients at three and six months as well as subsequent determination of health status at six-month intervals by phone. Pathological examination of the hearts of patients who died was also performed. RTI (Data Coordinating Center for the trial), Harvard Medical School (Clinical Coordinating Center for the trial), NHLBI and several MILIS investigators are involved in analyzing the extensive data base developed from the MILIS trial. This includes analyses of endpoint results for hyaluronidase and numerous data bank studies. Forty-one data bank studies have been approved by the MILIS Data Bank Committee which have resulted in 9 publications and over 20 presentations. It is anticipated that the remaining endpoint studies and 8-12 additional publications will have been completed by the end of July 14, 1986. This leaves approximately 20 active approved data bank studies to be completed. Several MILIS clinical investigators who have agreed to participate in the proposed grant have further research topics which may be explored using the MILIS data base. This includes 10 studies from the Harvard group. Support would ensure continued analysis of the MILIS data base so that the approved data bank studies will be completed as well as several additional studies of interest to NHLBI and the MILIS investigators.