Multicenter Investigation of Limitation of Infarct Size (MILIS)
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|ClinicalTrials.gov Identifier: NCT00000493|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : July 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia||Drug: propranolol Drug: hyaluronidase||Phase 3|
The study of methods for minimizing the mass of ischemic infarcted myocardium associated with a myocardial infarction was identified as a topic of research priority in the 1973 Report of the Panel Chairman for the Preparation of the National Heart, Blood Vessel, Lung, and Blood Program. In September 1976, the Institute convened a workshop involving 32 investigators active in this field, respondents to past solicitations, experts on the topic of collaborative clinical trials, members of previous review committees, and several members of the Cardiology Advisory Committee. The attendees were enthusiastic about the practicality and timeliness of a collaborative clinical trial in this field. The concept of collaborative clinical trials to protect ischemic myocardium was discussed by the Cardiology Advisory Committee in its meeting of September 22, 1976, and was recommended affirmatively and enthusiastically. This trial was part of the Institute's initiatives and was reviewed and favorably recommended by the National Heart, Lung, and Blood Advisory Council at its December 1976 meeting. The trial consisted of five clinical centers, six central laboratories, a clinical coordinating center, and a data coordinating center.
Randomized. Group A patients were randomized to propranolol therapy, hyaluronidase therapy, or control therapy; patients assigned to Group B (propranolol contraindicated) were assigned to hyaluronidase or control therapy. Single-blind for propranolol therapy, double-blind for hyaluronidase or control therapy; fixed sample. Detailed follow-up of clinical status and endpoints for a six-month period; annual health status follow-up thereafter.
The study completion date listed in this record was obtained from the "End Date" entered in the Query View Report (QVR).
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||September 1977|
|Actual Study Completion Date :||December 1985|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000493
|OverallOfficial:||Eugene Braunwald||Harvard Medical School, Peter Bent Brigham Hospital|
|OverallOfficial:||Allan Jaffee||Washington University School of Medicine|
|OverallOfficial:||James Willerson||University of Texas|