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Unstable Angina Pectoris Trial

This study has been completed.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00000486
  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 III

MedlinePlus related topics:   Angina    Coronary Artery Bypass Surgery    Heart Diseases   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized

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

Study Start Date:   January 1972

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
Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000486

Sponsors and Collaborators

Investigators
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    
  More Information


Publications:

Study ID Numbers:   5
First Received:   October 27, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000486
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Coronary Disease
Signs and Symptoms
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Angina Pectoris
Pain
Ischemia
Angina, Unstable
Chest Pain

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 29, 2008




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