Carotid Occlusion Surgery Study (COSS): Data Management Center

描述（由申请人提供）：本提案适用于爱荷华州大学公共卫生学院生物统计学系的临床试验统计和数据管理中心（CTSDMC），用于颈动脉闭塞手术研究（COSS），并涵盖CTSDMC的活动。William Powers博士正在为本试验的临床协调中心（CCC）提交一份单独的提案。本研究的目的是检验以下假设：通过颞浅动脉与大脑中动脉（STA-MCA）的手术吻合进行颅外-颅内（EC/IC）动脉搭桥术，当添加到最佳药物治疗时，尽管围手术期卒中和死亡，继发性同侧缺血性卒中（致死性和非致死性）在2年时，有症状的颈动脉闭塞患者和通过正电子发射断层扫描测量的氧摄取分数增加（PET）。这是一项随机、非盲、对照试验，372名参与者随机分为手术和非手术治疗组。符合临床入选标准且通过血管成像检查至少有一条颈动脉闭塞的受试者将有资格入组接受PET。如果符合PET标准，则受试者必须符合动脉造影标准才能进行随机化。所有随机化受试者将接受抗血栓药物和风险因素干预的最佳可用药物治疗，以预防后续卒中。每隔3个月对参与者进行24个月的随访。CTSDMC在临床和流行病学研究的设计和实施方面拥有超过30年的经验，并拥有超过14年的多中心临床试验数据协调中心经验。这些研究包括神经病学、肾脏病学和糖尿病方面的研究。CTSDMC工作人员已成功开发和操作了多中心试验的基于网络的数据输入系统和数据库，并在成功协调临床试验方面有着出色的记录。

DESCRIPTION (provided by applicant): This proposal is for the Clinical Trials Statistical and Data Management Center (CTSDMC) in the Department of Biostatistics, College of Public Health at the University of Iowa for the Carotid Occlusion Surgery Study (COSS) and covers the activities of the CTSDMC. Dr. William Powers is submitting a separate proposal for the Clinical Coordinating Center (CCC) for this trial. The goal of this study is to test the hypothesis that extra cranial-intra cranial (EC/IC) arterial bypass by surgical anastomosis of the superficial temporal artery to the middle cerebral artery (STA-MCA) when added to best medical therapy can reduce by 40%, despite perioperative stroke and death, subsequent ipsilateral ischemic stroke (fatal and non-fatal) at two years in patients with symptomatic carotid artery occlusion and increased oxygen extraction fraction measured by positron emission tomography (PET). This is a randomized, non-blinded, controlled trial in 372 participants randomized equally to surgical and non-surgical treatment. Participants who fulfill clinical entry criteria and who have carotid occlusion in at least one carotid artery by vascular imaging will be eligible for enrollment to undergo PET. If PET criteria is met then arteriographic criteria must be met for the participant to be randomized. All randomized participants will receive the best available medical treatment with anti-thrombotic agents and risk factor intervention to prevent subsequent stroke. Participants are followed for 24 months at 3 month intervals. The CTSDMC brings over 30 years experience in the design and implementation of clinical and epidemiology studies and over 14 years experience serving as the data coordinating center for multi-center clinical trials. These studies include studies in neurology, nephrology, and diabetes. The CTSDMC staff has successfully developed and operated web based data entry systems and databases for multi-center trials and have a excellent record in successfully coordinating clinical trials.