CABG PATCH TRIAL--DATA COORDINATING CENTER

CABG贴片试验--数据协调中心

• 批准号: 2028713
• 负责人: JOHN THOMAS BIGGER
• 金额: $ 37.42万
• 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 1998-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2028713
• 关键词: arrhythmia; clinical trials; coronary disorder; disease /disorder proneness /risk; electrocardiography; health care cost /financing; heart revascularization; human data; human therapy evaluation; implantable defibrillators; 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 follow-up. 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 贴片试验是一项多中心、随机对照临床试验 试验检验植入式心脏复律除颤器的假设 (ICD) 治疗将提高冠心病患者的生存率 死亡风险较高，尤其是心律失常死亡，即患有以下疾病的患者 严重的左心室功能障碍，也有心律失常的标志 风险（平均心电图正信号）。 为了解决这个问题，患者 如果患有冠心病，则将被纳入 动脉搭桥手术，年龄小于80岁，已离开 心室射血分数小于0.36，并有阳性信号 平均心电图。 这组患者与已经接受过治疗的患者相似 持续性室性心律失常，因此有适应症 根据现行指南进行 ICD 治疗。 另外，该集团拥有较高的 随访期间发生死亡的概率。 治疗和 对照组在慢性病的另一个重要方面非常匹配 冠心病 - 缺血事件的风险。 拥有两个组 试验开始时进行血运重建具有潜在优势 锐化终点，即所有死亡的比例较小 预计是缺血性的，并且预计更大比例 心律失常，一种通过治疗可以很好解决的病理生理学 正在研究中。 纳入的患者将在手术期间随机分组 是否接受 ICD。 我们计划将 800 名患者随机分组，其中一半 对照组和ICD组各一半。 患者将接受随访 随机化后平均三年。 CABG 修补试验有 80%-85% 的功效可以检测到 40 个月内假设的 40% 减少 ICD 治疗组全因死亡率的风险率。 在 此外，CABG 贴片试验将： 记录 ICD 的任何发病情况 治疗;评估 ICD 治疗对生活质量的影响；和 比较 ICD 治疗与对照组的医疗保健费用 团体。 在最狭义的解释中，结果将适用于高 接受冠状动脉搭桥术（CABG）手术的冠心病风险患者。 另外， 结果应该基本上适用于满足当前条件的患者 ICD 治疗和其他一些高危冠心病的适应症 尚未发生心律失常事件的疾病患者。