ASYMPTOMATIC CAROTID ARTERY STENOSIS COLLABORATIVE STUDY

无症状颈动脉狭窄合作研究

• 批准号: 3405234
• 负责人: JAMES F TOOLE
• 金额: $ 235.38万
• 依托单位: WAKE FOREST UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-09-09 至 1992-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3405234
• 关键词: artery stenosis; aspirin; cardiovascular disorder chemotherapy; cardiovascular disorder prevention; carotid artery; cerebral ischemia /hypoxia; cerebroangiography; cerebrovascular occlusions; endarterectomy; human subject; human therapy evaluation; ibuprofen; infarct; longitudinal human study; myocardial infarction; myocardial ischemia /hypoxia; stroke

This proposal is for an investigator initiated multicenter clinical trial of medical/surgical therapy to prevent stroke in asymptomatic patients with stenosis of the distal common and/or internal carotid artery. There are two components - a surgical and a medical. Surgical. The major aim of the surgical component is to compare the effectiveness of aspirin + endarterectomy versus aspirin alone in reducing the incidence of TIA and cerebral infarction in patients with asymptomatic hemodynamically significant stenosis of the carotid artery. A secondary objective is to determine the incidence of recurrent stenosis following carotid endarterectomy. Medical. The major aim of the medical component is to compare the effectiveness of aspirin versus ibuprofen versus a placebo in reducing the incidence of the primary endpoints of TIA, cerebral infarction, or progression to hemodynamically significant stenosis in patients with asymptomatic non-hemodynamically significant stenosis of the carotid artery. An important secondary aim is to make such a comparison in terms of the secondary endpoint of myocardial infarction or other cardiac ischemia in those patients with no such symptoms. Another secondary objective is to determine the relationship of the progression of carotid stenosis (from non-hemodynamically significant to hemodynamically significant) to the occurrence of cerebral ischemia (TIA or stroke). In the surgical component, follow-up will be for a minimum of five years and will evaluate the frequency and magnitude of subsequent neurological events and the recurrent stenosis rate at the operated site. In the medical component, follow-up will also be for a minimum of five years to evaluate the development of neurological symptoms and the rate of progression of stenosis as assessed by noninvasive studies.

本提案适用于研究者发起的多中心临床试验 药物/手术治疗以预防无症状患者中风 远端总动脉和/或颈内动脉狭窄。 有 两个组成部分——外科手术和医疗手术。 外科。 手术部分的主要目的是比较 阿司匹林+动脉内膜切除术与单用阿司匹林相比，在减少动脉粥样硬化方面的效果 无症状患者TIA和脑梗塞的发生率 颈动脉血流动力学显着狭窄。 二级 目的是确定术后狭窄复发的发生率 颈动脉内膜切除术。 医疗的。 医疗部分的主要目的是比较 阿司匹林、布洛芬、安慰剂在减少 主要终点 TIA、脑梗死或 患者进展为血流动力学显着狭窄 无症状、非血流动力学显着性颈动脉狭窄 动脉。 一个重要的次要目标是在术语上进行这样的比较 心肌梗塞或其他心脏疾病的次要终点 那些没有此类症状的患者出现缺血。 另一个中学 目的是确定颈动脉进展的关系 狭窄（从非血流动力学显着到血流动力学显着） 显着）的脑缺血（TIA或中风）的发生。 在手术部分，随访时间至少为五年 并将评估随后的神经系统疾病的频率和程度 事件和手术部位的复发性狭窄率。 在 医疗部分，后续行动也将持续至少五年 评估神经系统症状的发展和发生率 通过无创研究评估狭窄的进展。