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Clinical Trials/NCT01082783
NCT01082783
Completed
Not Applicable

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

Charite University, Berlin, Germany1 site in 1 country28 target enrollmentDecember 2009
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Charite University, Berlin, Germany
Enrollment
28
Locations
1
Primary Endpoint
autoantigen-specific T-cells in patients with acute media infarct
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
November 2011
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andreas Meisel

Professor Dr. med.

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: within 36 h

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

leukocytes in patients with acute media infarct

Time Frame: within 36 hours

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

Secondary Outcomes

  • 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)

Study Sites (1)

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