CABG PATCH TRIAL--ADMINISTRATIVE AND CLINICAL CENTERS

CABG 补片试验——行政和临床中心

• 批准号: 2647449
• 负责人: JOHN THOMAS BIGGER
• 金额: $ 18.95万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-03-12 至 1999-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2647449
• 关键词: antiarrhythmic agent; arrhythmia; atherosclerosis; clinical trials; coronary disorder; disease /disorder proneness /risk; health care cost /financing; heart disorder chemotherapy; heart surgery; human morbidity; human subject; human therapy evaluation; implant; implantable defibrillators; longitudinal human study; medical implant science; quality of life

The CABG Patch Trial is a multicenter, randomized controlled clinical trial to test the hypothesis that implantable cardioverter defibrillator (ICD) therapy will improve survival in coronary heart disease patients at high risk of death, especially arrhythmic death, i.e., patients with severe left ventricular dysfunction who also have a marker of arrhythmic risk (positive signal averaged ECG). To address this question, patients with coronary heart disease will be enrolled if they are having coronary artery bypass graft surgery, are less than 80 years of age, have left ventricular ejection fraction less than 0.36, and have a positive signal averaged ECG. This group is similar to the patients who already have had a sustained ventricular arrhythmia and therefore have an indication for ICD treatment under current guidelines. Also, the group has a high probability of experiencing death during followup. The treatment and control groups are well matched for another important aspect of chronic coronary heart disease - risk for ischemic events. Having both groups revascularized at the beginning of the trial has the potential advantage of sharpening the endpoint, i.e., a smaller proportion of all deaths are expected to be ischemic, and a larger proportion are expected to be arrhythmic, a pathophysiology that is addressed superbly by the treatment under study. Enrolled patients will be randomized during surgery to receive an ICD or not. We plan to randomize 800 patients, half to the control group and half to the ICD group. Patients will be followed for an average of three years after randomization. The CABG Patch Trial has 80%-85% power to detect a hypothesized 40% reduction in the 40-month hazard rate for all-cause mortality in the ICD treated group. In addition, The CABG Patch Trial will: document any morbidity of ICD treatment; evaluate the effects of ICD therapy on quality of life; and compare the health care costs of ICD treatment with those in the control group. In the narrowest interpretation, the results will apply to high risk coronary heart disease patients undergoing CABG surgery. Also, the results should apply substantially to patients who satisfy the current indications for ICD treatment and to some other high risk coronary heart disease patients who have not yet had an arrhythmic event.

CABG补片试验是一项多中心、随机对照临床试验， 一项试验旨在验证植入式心律转复除颤器 (ICD)治疗将提高冠心病患者的生存率， 死亡风险高，尤其是猝死，即，患者 严重的左心室功能不全， 风险（阳性信号平均ECG）。 为了解决这个问题，患者 如果患有冠心病， 动脉旁路移植手术，不到80岁，已经离开 心室射血分数小于0.36，并有阳性信号 平均ECG。 这组患者与已经接受过 持续性室性心律失常，因此有迹象表明， 根据现行指南进行ICD治疗。 此外，该集团有一个高 随访期间发生死亡的概率。治疗和 对照组在慢性炎症的另一个重要方面匹配良好， 冠心病-缺血性事件的风险。 拥有这两个群体 在试验开始时进行血运重建具有潜在的优势， 锐化端点，即，在所有死亡人数中， 预计会出现缺血性疾病，预计会有更大比例的患者 糖尿病是一种病理生理学， 正在研究中。 入组患者将在手术期间随机分配， 是否需要ICD 我们计划随机抽取800名患者， 对照组和ICD组各一半。 将对患者进行随访， 平均三年后随机分组。 冠状动脉旁路移植术贴片试验 80%-85%的把握度检测到40个月内假设的40%降低 ICD治疗组中全因死亡的风险率。 在 此外，CABG补片试验将：记录ICD的任何发病率 治疗;评价ICD治疗对生活质量的影响;以及 比较ICD治疗与对照组的医疗保健费用 组 在最后的解释中，结果将适用于高 冠状动脉搭桥手术的危险性冠心病患者。 还 结果应基本上适用于满足当前 ICD治疗和其他一些高危冠心病的适应症 尚未发生过腹泻事件的患者。