ASYMPTOMATIC CAROTID ARTERY STENOSIS COLLABORATIVE STUDY

无症状颈动脉狭窄合作研究

• 批准号: 3405241
• 负责人: JAMES F TOOLE
• 金额: $ 297.55万
• 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 1997-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3405241
• 关键词: angina pectoris; angiography; artery stenosis; aspirin; atherosclerosis; cardiovascular disorder chemotherapy; cardiovascular disorder prevention; carotid artery; carotid sinus; clinical trials; computed axial tomography; endarterectomy; human subject; human therapy evaluation; infarct; longitudinal human study; myocardial infarction; patient care management; prognosis; relapse /recurrence; statistics /biometry; stroke; transient ischemic attack; ultrasound blood flow measurement

This proposal is for a continuation of a prospective, multicenter randomized clinical trial of medical/surgical therapy to prevent TIA and stroke in asymptomatic patients with stenosis of the common carotid bulb and/or internal carotid sinus -- the site of more than 90% of hemodynamically significant carotid artery atherosclerosis. The major aim of the study is to determine whether the addition of carotid endarterectomy to aspirin (325 mg) + best medical management will reduce the incidence of TIA and cerebral infarction in asymptomatic patients with hemodynamically significant carotid stenosis. Secondary objectives are to determine: (1) the surgical success in lesion removal and incidence of recurrent carotid stenosis following carotid endarterectomy, (2) the rate of progression (or regression) of carotid atherosclerosis in the medically treated group and in the control carotid arterial system, and (3) the incidence of coronary artery events (angina pectoris, non-fatal and fatal myocardial infarction) during follow-up. Quality assurance is a major component in study design. The results of the North American Symptomatic Carotid Endarterectomy Trial have demonstrated that carotid endarterectomy is the treatment of choice for symptomatic carotid artery stenosis exceeding 70%. It is estimated that the symptomatic subset represents only 10% of the prevalence of carotid stenosis. Therefore, it is all the more urgent to determine whether similar results apply to asymptomatic patients.

这项提议是为了延续未来的多中心 预防TIA和TIA的内外科治疗的随机临床试验 无症状颈总动脉球部狭窄患者的卒中 和/或颈内动脉窦--超过90%的 血流动力学显着颈动脉粥样硬化。主要目标是 这项研究的目的是确定是否增加颈动脉内膜切除术 服用阿司匹林(325毫克)+最好的医疗管理将减少 血流动力学无症状患者TIA与脑梗塞 严重的颈动脉狭窄。次要目标是确定：(1) 手术切除病变的成功率与颈动脉复发的关系 颈动脉内膜切除术后的狭窄，(2)进展率(或 药物治疗组颈动脉粥样硬化的消退)和 在控制的颈动脉系统中，(3)冠状动脉的发生率 动脉事件(心绞痛、非致命性和致命性心肌梗死) 在随访期间。质量保证是研究设计的重要组成部分。 北美症状性颈动脉内膜切除术试验结果 已经证明颈动脉内膜切除术是治疗的首选 对于有症状的颈动脉狭窄超过70%。据估计， 有症状的子集仅代表10%的患病率 颈动脉狭窄。因此，更加迫切地需要确定 类似的结果是否适用于无症状的患者。