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补丁试验是一项多中心，随机控制的临床 试验以测试植入式心脏逆变器除颤器的假设 （ICD）治疗将改善冠心病患者的生存率 高死亡风险，尤其是心律不齐的死亡，即患者 严重的左心室功能障碍，也有心律不齐的标记 风险（正信号平均ECG）。 为了解决这个问题，病人 如果冠状动脉患有冠状动脉 动脉搭桥手术手术不到80岁，已经离开 心室射血分数小于0.36，并具有正信号 平均心电图。 这组与已经已经有过的患者相似 持续的心室心律不齐，因此有指示 ICD治疗当前指南。 此外，该小组的高度很高 随访期间经历死亡的可能性。治疗和 对照组与慢性的另一个重要方面非常匹配 冠心病 - 缺血性事件的风险。 都有两组 试验开始时血运重建具有潜在的优势 尖锐的终点，即，所有死亡中的较小比例是 预计将是缺血性的，预计更大的比例为 心律不齐，一种病理生理学，通​​过治疗扎根 正在研究。 在手术期间，入学的患者将随机分配给 是否收到ICD。 我们计划将800名患者随机，一半 对照组，ICD组的一半。 将遵循患者 随机分组后平均三年。 CABG补丁试用 80％-85％的功率可检测假设的40％降低40％ ICD处理组中全因死亡率的危险率。 在 此外，CABG补丁试验将：记录ICD的任何发病率 治疗;评估ICD治疗对生活质量的影响；和 将ICD治疗的医疗保健费用与控制的人进行比较 团体。 在最狭窄的解释中，结果将适用于高 风险冠心病患者接受CABG手术。 另外， 结果应大大适用于满足当前的患者 ICD治疗的适应症和其他一些高风险冠心心 尚未发生心律不齐的疾病患者。