POST CORONARY ARTERY BYPASS GRAFT STUDY

该承包商将成为 协作性临床试验，冠状动脉搭桥术后 嫁接)研究。这个项目的主要目标是 确定是通过药物治疗还是通过药物治疗降低血清胆固醇 改变生活方式(饮食锻炼和戒烟) 将对长期(1之后)的比率产生有利影响 年)移植物再闭塞。冠状动脉搭桥术后将是一个随机的临床 试验也将包括生物行为部分和 流行病学研究部分。该计划的目标是 生物行为研究的组成部分是确定生物行为和 有助于成功适应的心理社会因素 冠状动脉旁路移植术后。流行病学研究部分的目标 是确定临床、生化和止血因素 与自发性冠状动脉粥样硬化和移植物相关 遮挡。试验的辅助目标包括评估 干预措施对(1)冠状动脉病变进展的影响 自体血管和内乳房移植物的动脉粥样硬化； (2)心功能；(3)发病率；(4)生活质量。 具体地说，协调中心将以 期间参与试验设计的职责 第一阶段，收集、编辑、存储和分析数据 由临床中心在第二阶段产生。它将提供 积累数据和临床中心的详细报告 数据和安全每隔六个月执行一次 第二阶段的监督委员会。协调中心将 在患者终止后获得两年的支持 跟进以完成研究数据的分析并协助 编制科学报告以供出版和提交 (第三阶段)。

This contractor will be the Coordinating Center for the collaborative clinical trial, PostCABG (Coronary Artery Bypass Graft) Study. The primary objective of this project is to determine if lowering serum cholesterol by drug treatment or by lifestyle modification (dietary exercise, and cessation of smoking) will have a beneficial effect on the rate of longterm (after 1 year) graft reocclusion. PostCABG will be a randomized clinical trial which will also have a biobehavioral component and an epidemiologic study component. The objective of the biobehavioral study component is to identify the biobehavioral and psychosocial factors that contribute to the successful adjustment after CABG. The objective of the epidemiologic study component is to identify clinical, biochemical and hemostatic factors that correlate with native coronary atherosclerosis and graft occlusion. Subsidiary objectives of the trial include assessing the effects of interventions on (1) progression of coronary atherosclerosis in the native vessels and internal mammary grafts; (2) ventricular function; (3) morbidity; and (4) quality of life. Specifically, the Coordinating Center will have as its major responsibilities participation in the design of the trial during Phase I, and collecting, editing, storing, and analyzing data generated by the clinical centers during Phase II. It will provide a detailed report of accumulating data and clinical centers performance at sixmonth intervals for the Data and Safety Monitoring Board during Phase II. The Coordinating Center will be supported for two years beyond termination of patient followup to complete analysis of study data and assist in preparation of scientific reports for publication and presentation (Phase III).