CLINICAL UNIT FOR ASYMPTOMATIC CARDIAC ISCHEMIA PILOT

无症状心脏缺血飞行员的临床单位

• 批准号: 3658776
• 负责人: WILLIAM J. ROGERS
• 金额: $ 14.42万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-12-10 至 1994-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3658776
• 关键词: angina pectoris; angiography; clinical trials; coronary disorder; electrocardiographic monitor; exercise; heart disorder diagnosis; heart revascularization; human subject; human therapy evaluation; myocardial ischemia /hypoxia; radionuclide diagnosis; therapy compliance

The purpose of this program is to conduct a multicenter trial as a pilot study to assess the feasibility of and test the methodology required for a full scale clinical trial of asymptomatic cardiac ischemia therapies. The primary objective is to determine the relative efficacy of usual care, stepped medical therapy, and mechanical revascularization to provide freedom from myocardial ischemia. Other objectives are to confirm the frequency of asymptomatic cardiac ischemia in the target patient subgroups, validate current detection and monitoring systems, and clarify other issues important for a full scale clinical trial, such as the availability of patients for randomization and compliance with assigned prescription. The study population will consist of a total of 600 patients with coronary artery disease (CAD), documented by angiographic and radionuclide studies, who have been identified by both exercise stress testing and 48 hour ambulatory ECG monitoring: 300 patients with CAD and exertional angina and 300 patients with asymptomatic CAD. Within each stratum, patients will be randomized to three treatment strategies: usual, symptom-guided care; maximal medical, ambulatory ECG-directed, stepped care therapy; and mechanical revascularization. The primary endpoint will be a reduction of total and asymptomatic cardiac ischemia detected by ambulatory ECG monitoring. This contract is for a Clinical Unit for patient accession, intervention, and data collection.

该计划的目的是进行多中心试验作为试点