Clinical trial NCT01082783: Autoimmune Phenomena After Acute Stroke
Official title: Autoimmune Phenomena After Acute Stroke - the Role of Stroke-induced Immunodepression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke-induced immunodepression
acute media infarct
acute intracerebral bleeding
leucocytes
autoaggressive T-cells
acute media infarct or acute intracerebral bleeding
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: NeuroCure Clinical Research Center, Charite, Berlin
First posted: 2010-03-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: acute media infarct or intracerebral bleeding

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.


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

Primary outcomes:
measure: autoantigen-specific T-cells in patients with acute media infarct
timeFrame: within 36 h
measure: leukocytes in patients with acute media infarct
timeFrame: within 36 hours
Secondary outcomes:
measure: frequency and phenotype of CNS-autoreactive immune cells under the influence of immunodepression
timeFrame: within 36 h, after day 3, 7, 90 and 180
measure: clinical course, i.e. mortality and prognosis (measured by mod. Rankin Scale)
timeFrame: after day 90 and 180
measure: clinical course, i.e. mortality and prognosis (measured by Bartel Index)
timeFrame: after day 90 and 180
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Andreas Meisel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.