Unstable Angina Pectoris Trial

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000486
• Other study ID #: 5
• Status: Completed
• Phase: Phase 3
• First received: October 27, 1999
• Last updated: November 25, 2013
• Start date: January 1972
• Est. completion date: January 1980

Study information

• Verified date: January 2000
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 1980
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Unstable
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Procedure:
• coronary artery bypass

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (3)

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. — View 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. — View 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. — View Citation