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临床试验/NCT00860184
NCT00860184Unknown不适用

Assessment of MRI-based Prediction of Stroke and Other Cerebrovascular Symptoms Arising From Carotid Atherosclerotic Disease in Asymptomatic Individuals

VPDiagnostics15 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
15
主要终点
stroke or other cerebrovascular symptom (e.g. TIA)

研究概览

简要总结

Atherosclerotic plaque at the carotid artery bifurcation is a major source of stroke. The purpose of this investigation is to determine the ability of the SmartRisk software module to predict stroke or stroke-related events due to carotid plaque within a high-risk population. The SmartRisk software module operates on magnetic resonance images (MRI) of the carotid artery wall.

详细描述

Carotid artery disease (atherosclerosis) is a major cause of stroke that can be treated with carotid endarterectomy surgery (CEA) or stenting. Subjects with moderate, asymptomatic stenosis (50-79% narrowing) typically do not undergo intervention because the procedural risks outweigh the benefits. However, some of these individuals will have vulnerable plaque that places them at high risk of stroke, but current diagnostic techniques for vulnerable plaque are lacking. Recently, VPDiagnostics developed a new module - SmartRisk - that stratifies risk of stroke for stenotic (50-79% blockage) atherosclerotic plaque. The SmartRisk module uses MRI data to compute a risk assessment from a specific atherosclerotic plaque. A continuous risk value is generated and patients with risk values above a prespecified threshold are at elevated risk for cerebrovascular events arising from carotid artery disease. The purpose of this trial is to determine whether the SmartRisk module is effective at stratifying risk of a carotid-related cerebrovascular event in subjects with asymptomatic 50-79% carotid stenosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50-79% stenosis of the carotid artery
  • age 18 or older
  • no ischemic neurovascular symptoms within preceding 6 months

排除标准

  • contraindication to MRI (e.g. weight > 130 kg, pregnancy)
  • prior or planned carotid endarterectomy or stenting
  • history of atrial fibrillation
  • prior neck irradiation

结局指标

主要结局

stroke or other cerebrovascular symptom (e.g. TIA)

时间窗: 18 month mean follow-up at 6 month intervals

次要结局

  • any cardiovascular event (e.g. MI)(18 month mean follow-up at 6 month intervals)

研究者

发起方
VPDiagnostics
申办方类型
Industry

研究点 (15)

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