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Trial NCT00000486

Resource URI: http://static.linkedct.org/resource/trials/NCT00000486
linkedct:brief_title Unstable Angina Pectoris Trial
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:condition <http://static.linkedct.org/resource/condition/974>
linkedct:criteria Men and women, ages 21 to 65. Angina pectoris (class III or class IV) at rest or with minimal exercise.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 65 Years
linkedct:eligibility_minimum_age 21 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000486
rdfs:label Trial NCT00000486
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000486
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 5
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/2904>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/29425>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/34875>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/35074>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/458>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/50008>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000486>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/16848>
linkedct:reference <http://static.linkedct.org/resource/reference/40343>
linkedct:reference <http://static.linkedct.org/resource/reference/44103>
linkedct:reference <http://static.linkedct.org/resource/reference/44105>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date January 1972
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date January 2000