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临床试验/NCT01082783
NCT01082783已完成不适用

Autoimmune Phenomena After Acute Stroke - the Role of Stroke-induced Immunodepression

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
autoantigen-specific T-cells in patients with acute media infarct

研究概览

简要总结

The damage of the brain parenchyma, as well as the stroke-induced dysfunction of the blood-brain-barrier can make previously hidden CNS antigens "visible", and can thus lead to the development of autoimmune mechanisms.

It seems plausible that stroke-associated immunodepression influences the development and the phenotype of these autoreactive immune responses.

This study will investigate whether cerebral ischemia leads to changes in the immune response, in particular to the development and/or proliferation of autoreactive effector T-cells and/or regulatory T-cells. Furthermore, the association between the severity and the phenotype of this autoimmune response and the clinical course, i.e. prognosis and mortality, will be investigated.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • acute media infarct or intracerebral bleeding within the last 36 h (patients)
  • NIHSS > 7 (patients)
  • age > 17 years (patients), age > 54 years (controls)
  • informed consent of patient or legal representative/ of control
  • cardiovascular risk such as diabetes mellitus (control)

排除标准

  • infections (patients, controls)
  • antibiotic or immunosuppressive treatment within the last 4 weeks (patients)
  • other CNS disorders

结局指标

主要结局

autoantigen-specific T-cells in patients with acute media infarct

时间窗: within 36 h

quantitative determination of autoantigen-specific T-cells in patients with acute media infarct

leukocytes in patients with acute media infarct

时间窗: within 36 hours

quantitative and qualitative analysis of leukocytes in patients with acute media infarct

次要结局

  • frequency and phenotype of CNS-autoreactive immune cells under the influence of immunodepression(within 36 h, after day 3, 7, 90 and 180)
  • clinical course, i.e. mortality and prognosis (measured by mod. Rankin Scale)(after day 90 and 180)
  • clinical course, i.e. mortality and prognosis (measured by Bartel Index)(after day 90 and 180)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Meisel

Professor Dr. med.

Charite University, Berlin, Germany

研究点 (1)

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