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临床试验/NCT05920902
NCT05920902招募中不适用

Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Progressively deterioration in acute phase

研究概览

简要总结

Establish a clinical cohort of acute ischemic stroke patients and find the determinant of the prognosis.

详细描述

  1. Enrollment: screening the candidates based on the inclusion and exclusion criteria, and sign the informed consent.
  2. Baseline evaluation: evaluate baseline situation of enrolled candidates.
  3. Inpatient view: view and evaluate enrolled candidates respectively at day 1, 3, 7 and 14 after stroke, and record the results.
  4. Follow-up: view the candidates at 90 days and one year after stroke onset, and record the results.
  5. Data analysis: analyze the results.

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
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 30-90, no gender restrictions.
  • Onset of disease ≤7 days.
  • Meet either of the following two conditions:
  • ① Transient ischemic attack (TIA)
  • ② Ischemia stroke (IS) Note: Acute IS diagnosis criteria: sudden and persistent focal or widespread neurological dysfunction, excluding other non-vascular causes of brain dysfunction (such as brain infection, head injury, brain tumor, epilepsy, severe metabolic diseases, or degenerative neurological diseases), confirmed by image as new IS. TIA diagnosis criteria: sudden and reversible focal neurological or retinal ischemic deficit caused by a reversible ischemia, usually lasting less than 24 hours, with no evidence of new IS on imaging, and excluding other non-ischemic causes (such as brain infection, head injury, brain tumor, epilepsy, severe metabolic diseases, or degenerative neurological diseases).
  • Signed informed consent

排除标准

  • Clear cause of ischemic stroke other than atrial fibrillation.
  • Other ischemic strokes with a clear cause.
  • Presence of non-vascular intracranial disease.
  • Presence of severe systemic diseases.
  • Pregnancy or lactation.
  • Unable to tolerate or cooperate with MRI examination.
  • Unable to comply with follow-up due to geographical or other reasons.

结局指标

主要结局

Progressively deterioration in acute phase

时间窗: 7 days after ischemia stroke onset

Number of participants whose SNOB (Standardised nursing observations for stroke) score at 7 days post ischemia stroke ≤ 2 points compared to baseline, and/or NIHSS score at 7 days post ischemia stroke ≥ 2 points compared to baseline are identified as progressively deterioration in acute phase.

Bad prognosis of acute ischemia stroke

时间窗: 90 days after ischemia stroke onset

Number of participants whose mRS (Modified rankin scale) score at 90 days after ischemia \> 2 are identified as bad prognosis.

次要结局

  • Recurrent vascular episode(1 year)
  • Recurrent artery stenosis(one year after stenting)
  • Unhealthy status(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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