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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina, Unstable

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 27, 1999
    Last Updated
    November 25, 2013
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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

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    Unstable Angina Pectoris Trial

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