Autoimmune Phenomena After Acute Stroke

NCT01082783 | Completed

• 1 other identifier: ARIMIS
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke-induced immunodepression; acute media infarct; acute intracerebral bleeding; leucocytes; autoaggressive T-cells; acute media infarct or acute intracerebral bleeding

Outcome Measures

Primary Outcomes (2)

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

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

  within 36 h

• leukocytes in patients with acute media infarct

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

  within 36 hours

Secondary Outcomes (3)

• 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 Arms (2)

patients with acute media infarct

controls with cardiovascular risks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

acute media infarct or intracerebral bleeding

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• NeuroCure Clinical Research Center, Charite, Berlin: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

• Klehmet J, Hoffmann S, Walter G, Meisel C, Meisel A. Stroke induces specific alteration of T memory compartment controlling auto-reactive CNS antigen-specific T cell responses. J Neurol Sci. 2016 Sep 15;368:77-83. doi: 10.1016/j.jns.2016.06.039. Epub 2016 Jun 17.

  PMID: 27538605 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples (serum and plasma)

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andreas Meisel, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: December 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

DE (1)