Clinical trial NCT00000486: Unstable Angina Pectoris Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Angina, Unstable
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility criteria: Men and women, ages 21 to 65. Angina pectoris (class III or class IV) at rest or with minimal exercise.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Lewis Becker
affiliation: Massachusetts General Hospital
name: Adolph Hutter
affiliation: University of Chicago
name: Leon Resnekov
affiliation: University of Alabama at Birmingham
name: Richard Russell
affiliation: Stanford University
name: John Schroeder
affiliation: Duke University
name: Andrew Wallace
References:
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.
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.
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.