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Unstable Angina Pectoris Trial

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000486
First received: October 27, 1999
Last updated: June 23, 2005
Last verified: January 2000
History of Changes

October 27, 1999
June 23, 2005
January 1972
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Complete list of historical versions of study NCT00000486 on ClinicalTrials.gov Archive Site
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Unstable Angina Pectoris Trial
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To compare the efficacy of medical or surgical (coronary artery bypass graft) therapy with regard to survival and quality of life in patients with unstable angina and requisite coronary anatomy as defined by angiography.

BACKGROUND:

Angina pectoris is a symptomatic condition of attacks of chest pain, often debilitating. It is caused by a decreased supply of blood to the heart, such as that which might occur in coronary artery disease. The usual treatment of angina pectoris is designed to relieve the symptoms. It includes avoidance of activities that produce the discomfort and the use of nitroglycerin and beta blocking drugs. Soon after the introduction of coronary bypass surgery, many doctors enthusiastically adopted this approach in treating patients with unstable angina.

In 1972, emphasizing that there was no definitive evidence showing the superiority of intensive medical management or coronary bypass surgery in determining mortality and morbidity in patients hospitalized with unstable angina, some of the participating groups in the NHLBI Myocardial Infarction Research Units developed a cooperative clinical trial to compare these medical and surgical approaches to therapy.

From 1972 through 1976, 288 patients were entered into this randomized clinical trial. One hundred forty-seven patients received intensive pharmacological medical therapy, and 141 comparable patients underwent coronary artery bypass surgery. Careful follow-up studies were performed on patients in both groups, in-hospital and during the post-hospital phase. These studies included, apart from routine physical examinations, resting electrocardiograms, chest x-ray films, and grade exercise tolerance tests at six months and twelve months.

DESIGN NARRATIVE:

Randomized, non-blind, sequential design with a control group and an experimental group. The patients in the experimental group were treated with coronary bypass surgery. Patients in the control group received intensive medical management. Endpoints were mortality and morbidity measures, such as incidence of myocardial infarction and persistence of angina.
Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
  • Angina, Unstable
  • Cardiovascular Diseases
  • Coronary Disease
  • Heart Diseases
  • Myocardial Ischemia
Procedure: coronary artery bypass
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Men and women, ages 21 to 65. Angina pectoris (class III or class IV) at rest or with minimal exercise.
Both
21 Years to 65 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00000486
5
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Lewis Becker Johns Hopkins University
Investigator: Adolph Hutter Massachusetts General Hospital
Investigator: Leon Resnekov University of Chicago
Investigator: Richard Russell University of Alabama at Birmingham
Investigator: John Schroeder Stanford University
Investigator: Andrew Wallace Duke University
National Heart, Lung, and Blood Institute (NHLBI)
January 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP