Carotid Occlusion Surgery Study (COSS): Data Management Center

本提案是为爱荷华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）进行颈动脉闭塞手术研究（COSS），并涵盖CTSDMC的活动。威廉·鲍尔斯博士正在为临床协调中心（CCC）提交一份关于这项试验的单独提案。本研究的目的是验证这样一种假设，即在最佳药物治疗的基础上，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，尽管围手术期卒中和死亡，但仍可减少40%。通过正电子发射断层扫描（PET）测量有症状的颈动脉闭塞和氧提取分数增加的患者，两年后发生同侧缺血性中风（致命和非致命）。这是一项随机、非盲、对照试验，共有372名参与者随机接受手术和非手术治疗。符合临床入组标准且经血管成像至少有一条颈动脉闭塞的参与者将有资格入组接受PET。如果符合PET标准，则必须符合动脉造影标准才能随机分配参与者。所有随机参与者将接受抗血栓药物和危险因素干预的最佳药物治疗，以预防随后的卒中。每隔3个月对参与者进行为期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30多年的经验，并在多中心临床试验中担任数据协调中心超过14年。这些研究包括神经学、肾脏病学和糖尿病的研究。CTSDMC工作人员成功地开发和操作了基于web的数据输入系统和多中心试验数据库，并在成功协调临床试验方面取得了优异的成绩。

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.