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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00000493 |
To assess the ability of two separate therapeutic interventions, propranolol and hyaluronidase, to limit the ultimate size of an acute myocardial infarction. A secondary objective was to assess the influence of these therapies upon ventricular function and morbidity following myocardial infarction.
Condition | Intervention | Phase |
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Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia |
Drug: propranolol Drug: hyaluronidase |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Study Start Date: | September 1977 |
Estimated Study Completion Date: | December 1985 |
BACKGROUND:
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.
DESIGN NARRATIVE:
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.
Ages Eligible for Study: | 18 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Men and women, under age 75. Documented myocardial infarction which could be treated within 18 hours of onset of ischemic symptoms.
Investigator: | Eugene Braunwald | Harvard Medical School, Peter Bent Brigham Hospital |
Investigator: | Allan Jaffee | Washington University School of Medicine |
Investigator: | James Willerson | University of Texas |
Study ID Numbers: | 12 |
Study First Received: | October 27, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000493 |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Coronary Disease Necrosis Heart Diseases Propranolol Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Infarction Myocardial Infarction Coronary Artery Disease |
Vasodilator Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Pathologic Processes Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Anti-Arrhythmia Agents |