Connolly S J, Gent M, Roberts R S, Dorian P, Green M S, Klein G J, Mitchell L B, Sheldon R S, Roy D
McMaster Clinic, Hamilton General Hospital, McMaster University, Hamilton, Ontario, Canada.
Am J Cardiol. 1993 Nov 26;72(16):103F-108F. doi: 10.1016/0002-9149(93)90972-f.
The Canadian Implantable Defibrillator Study (CIDS) is an on-going randomized multicenter clinical trial that compares implantable cardioverter-defibrillator (ICD) therapy against amiodarone in patients with prior cardiac arrest or hemodynamically unstable ventricular tachycardia. Eligible patients are equally randomized to receive or not receive an ICD as initial management. Those not receiving an ICD receive amiodarone. All patients are seen in follow-up every 6 months. The primary outcome event cluster is arrhythmic death or any other death occurring within 30 days of therapy initiation. Secondary outcomes are all-cause mortality and nonfatal occurrences of ventricular tachycardia or fibrillation. The goal of the study is to recruit 400 patients over 4 years. All patients will be followed to the end of the year. This will result in an 80% chance of detecting a reduction in arrhythmic death of 58% by ICD if such a difference in truth exists. Recruitment began in October 1990 and 184 patients have been enrolled to date.
加拿大植入式除颤器研究(CIDS)是一项正在进行的随机多中心临床试验,该试验比较了植入式心脏复律除颤器(ICD)治疗与胺碘酮对曾发生心脏骤停或血流动力学不稳定的室性心动过速患者的疗效。符合条件的患者被随机分为接受或不接受ICD作为初始治疗。未接受ICD的患者接受胺碘酮治疗。所有患者每6个月接受一次随访。主要结局事件组是心律失常性死亡或在治疗开始后30天内发生的任何其他死亡。次要结局是全因死亡率以及室性心动过速或颤动的非致命性发作。该研究的目标是在4年内招募400名患者。所有患者将被随访至年底。如果确实存在这种差异,这将有80%的机会检测到ICD使心律失常性死亡降低58%。招募工作于1990年10月开始,迄今已招募了184名患者。