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Unstable Angina Pectoris Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000486
First Posted: October 28, 1999
Last Update Posted: November 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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.

Condition Intervention Phase
Angina, Unstable Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Procedure: coronary artery bypass Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: January 1972
Study Completion Date: January 1980
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women, ages 21 to 65. Angina pectoris (class III or class IV) at rest or with minimal exercise.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00000486


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Lewis Becker Johns Hopkins University
OverallOfficial: Adolph Hutter Massachusetts General Hospital
OverallOfficial: Leon Resnekov University of Chicago
OverallOfficial: Richard Russell University of Alabama at Birmingham
OverallOfficial: John Schroeder Stanford University
OverallOfficial: Andrew Wallace Duke University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000486     History of Changes
Other Study ID Numbers: 5
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: November 26, 2013
Last Verified: January 2000

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Angina, Unstable
Pathologic Processes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms