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临床试验/NCT02705599
NCT02705599已完成不适用

Stroke Mechanism Evolution in Intracranial Atherosclerotic Stenosis

Chinese PLA General Hospital2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
试验地点
2
主要终点
Ischemic stroke event (in the stenotic vascular territory)

研究概览

简要总结

Predictors of the risk of recurrent stroke for patients with symptomatic intracranial atherosclerotic stenosis (ICAS) remain unknown. The study will be to explore the stroke mechanism evolution in patients with ICAS by multi-model magnetic resonance imaging (MRI) which consists of diffusion-weighted imaging (DWI) and high-resolution MRI (HRMRI). The patients with symptomatic ICAS will undergo multi-model MRI. The baseline data, infarct patterns on DWI, and plaque features on HRMRI will be collected. The stroke mechanisms will be determined by the infarct patterns. During the 2 years follow-up, the recurrent ischemic events will be recorded. By comparing the baseline data, infarct patterns, and plaque features in patients with and without recurrent strokes, the high-risk features of patients with symptomatic ICAS will be identified. The evaluation of stroke mechanisms of patients with symptomatic ICAS will be summarized.

详细描述

Objective:

Primary objective: to identify which plaque features on HRMRI in patients with symptomatic ICAS are related to recurrent stroke.

Secondary objectives: To compare plaque features in subgroups.

Patients enrollment please see Eligibility part.

Methods:

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

  • 未提供

排除标准

  • Non-atherosclerosis vasculopathy such as vasculitis and arterial dissection diagnosed by comprehensive laboratory work (such as erythrocyte sedimentation rate or C-reactive protein elevations, antinuclear antibody, or antiphospholipid antibody positivity), vascular imaging, and clinical evaluation;
  • Contraindication to MR examination, medical instability precluding MR examination.

结局指标

主要结局

Ischemic stroke event (in the stenotic vascular territory)

时间窗: To 2 years

The primary outcome will include ischemic stroke (in the stenotic vascular territory) and vascular death.

次要结局

  • Ischemic stroke event (in the non-stenotic vascular territory)(To 2 years)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xin Lou

Deputy Chief

Chinese PLA General Hospital

研究点 (2)

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