Carotid Occlusion Surgery Study (COSS): Data Management Center

颈动脉闭塞手术研究 (COSS)：数据管理中心

• 批准号: 7696309
• 负责人: William R. Clarke
• 金额: $ 106.71万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-03-07 至 2012-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7696309
• 关键词: Biometry; Blinded; Blood Vessels; Bypass; Carotid Arteries; Cephalic; Certification; Cessation of life; Clinical; Clinical Trials; Communication; Data; Data Analyses; Data Coordinating Center; Databases; Diabetes Mellitus; Enrollment; Ensure; Failure; Financial Activity; Goals; Image; Internet; Intervention; Iowa; Ipsilateral; Ischemic Stroke; Leadership; Manuscripts; Measures; Medical; Methods; Monitor; Multi-Institutional Clinical Trial; Nephrology; Neurology; North Carolina; Online Systems; Operative Surgical Procedures; Oxygen; Participant; Patients; Perioperative; Positioning Attribute; Positron-Emission Tomography; Preparation; Principal Investigator; Procedures; Progress Reports; Public Health; Quality Control; Randomized; Records; Reporting; Research Personnel; Risk Factors; Role; Secure; Source; Staging; Stroke; Surgical Anastomosis; System; Temporal Arteries; Testing; Training; United States Food and Drug Administration; Universities; Washington; artery occlusion; clinical epidemiology; college; data acquisition; data management; day; design; experience; hemodynamics; middle cerebral artery; payment; prevent; programs; quality assurance

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.

该建议是针对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）的，用于颈动脉闭塞手术研究（COSS），并涵盖CTSDMC的活动。威廉·鲍尔斯（William Powers）博士正在为此试验提交临床协调中心（CCC）的单独建议。这项研究的目的是测试以下假说：额外的颅内颅（EC/IC）动脉旁路通过手术吻合术对表面颞动脉的手术吻合到中部大脑中动脉（STA-MCA），即使在最佳医疗治疗中添加到最佳医用治疗中，尽管围手术和死亡，但仍有两年的IPSILATIAL IPSILATAIL STROKE，但仍可以减少40％的医疗疗法，但仍可以减少40％。颈动脉阻塞和通过正电子发射断层扫描（PET）测量的氧气提取部分的增加。这是一项随机，非盲人，对照试验，在372名参与者中，同样将手术和非手术治疗随机分配。符合临床进入标准并通过血管成像中至少有一个颈动脉的颈动脉闭塞的参与者有资格参加宠物。如果满足PET标准，则必须满足动脉标准，才能随机分组参与者。所有随机参与者都将接受抗栓性药物和危险因素干预措施的最佳医疗治疗，以防止随后中风。参与者以3个月的间隔进行24个月。 CTSDMC在临床和流行病学研究的设计和实施方面具有30多年的经验以及作为多中心临床试验数据协调中心的14年以上的经验。这些研究包括神经病学，肾脏病和糖尿病的研究。 CTSDMC员工已成功开发和操作了基于Web的数据输入系统和数据库，用于多中心试验，并在成功协调临床试验方面具有出色的记录。