Autoimmune Phenomena After Acute Stroke

Completed

• Conditions: Stroke

• Registration Number: NCT01082783
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
autoantigen-specific T-cells in patients with acute media infarct	within 36 h	quantitative determination of autoantigen-specific T-cells in patients with acute media infarct
leukocytes in patients with acute media infarct	within 36 hours	quantitative and qualitative analysis of leukocytes in patients with acute media infarct

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany