ASYMPTOMATIC CAROTID ARTERY STENOSIS

无症状颈动脉狭窄

• 批准号: 2264565
• 负责人: JAMES F TOOLE
• 金额: $ 148.3万
• 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/2264565
• 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.

该提议是为了延续潜在的，多中心 医学/手术疗法的随机临床试验，以防止TIA和 无症状的颈动脉鳞茎狭窄患者的中风 和/或内部颈动脉窦 - 超过90％的地点 血液动力学意义上的颈动脉动脉粥样硬化。 主要目标 该研究的是确定是否添加颈动脉内膜切除术 到阿司匹林（325 mg） +最佳医疗管理将减少 无症状的血液动力学患者的TIA和脑梗塞 大量的颈动脉狭窄。 次要目标是确定：（1） 颈动脉的病变清除和发生率的手术成功 颈动脉内膜切除术后的狭窄，（2）进展速率（或 在医学治疗组中的颈动脉粥样硬化的回归）和 在控制颈动脉系统中，（3）冠状动脉的发生率 动脉事件（心绞痛，非致命和致命心肌梗塞） 在随访期间。 质量保证是研究设计的主要组成部分。 北美有症状的颈动脉内膜切除术试验的结果 已经证明颈动脉内膜切除术是选择的治疗 有症状的颈动脉狭窄超过70％。 估计 有症状的子集仅占患病率的10％ 颈动脉狭窄。 因此，确定 类似的结果是否适用于无症状患者。