Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000486
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Unstable Angina Pectoris Trial
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: