Unstable Angina Pectoris Trial
Primary Purpose
Angina, Unstable, Cardiovascular Diseases, Coronary Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
coronary artery bypass
Sponsored by
About this trial
This is an interventional treatment trial for Angina, Unstable
Eligibility Criteria
Men and women, ages 21 to 65. Angina pectoris (class III or class IV) at rest or with minimal exercise.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000486
First Posted
October 27, 1999
Last Updated
November 25, 2013
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000486
Brief Title
Unstable Angina Pectoris Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2000
Overall Recruitment Status
Completed
Study Start Date
January 1972 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 1980 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina, Unstable, Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
coronary artery bypass
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Men and women, ages 21 to 65. Angina pectoris (class III or class IV) at rest or with minimal exercise.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lewis Becker
Organizational Affiliation
Johns Hopkins University
First Name & Middle Initial & Last Name & Degree
Adolph Hutter
Organizational Affiliation
Massachusetts General Hospital
First Name & Middle Initial & Last Name & Degree
Leon Resnekov
Organizational Affiliation
University of Chicago
First Name & Middle Initial & Last Name & Degree
Richard Russell
Organizational Affiliation
University of Alabama at Birmingham
First Name & Middle Initial & Last Name & Degree
John Schroeder
Organizational Affiliation
Stanford University
First Name & Middle Initial & Last Name & Degree
Andrew Wallace
Organizational Affiliation
Duke University
12. IPD Sharing Statement
Citations:
PubMed Identifier
1266755
Citation
Unstable angina pectoris: national cooperative study group to compare medical and surgical therapy. I. Report of protocol and patient population. Am J Cardiol. 1976 May;37(6):896-902. doi: 10.1016/0002-9149(76)90116-8.
Results Reference
background
PubMed Identifier
6965816
Citation
Unstable angina pectoris: national cooperative study group to compare surgical and medical therapy. III. Results in patients with S-T segment elevation during pain. Am J Cardiol. 1980 Apr;45(4):819-24. doi: 10.1016/0002-9149(80)90127-7. No abstract available.
Results Reference
background
PubMed Identifier
6965333
Citation
Russell RO Jr, Wayne JB, Kronefeld J, Charles ED, Oberman A, Kouchoukos NT, White C, Rogers W, Mantle JA, Rackley CE. Surgical versus medical therapy for treatment of unstable angina: changes in work status and family income. Am J Cardiol. 1980 Jan;45(1):134-40. doi: 10.1016/0002-9149(80)90231-3. No abstract available.
Results Reference
background
Learn more about this trial
Unstable Angina Pectoris Trial
We'll reach out to this number within 24 hrs