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Autoimmune Phenomena After Acute Stroke (ARIMIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082783
First Posted: March 9, 2010
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
March 8, 2010
March 9, 2010
June 14, 2017
December 2009
November 2011   (Final data collection date for primary outcome measure)
  • 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
  • leukocytes in patients with acute media infarct [ Time Frame: within 36 h, after day 3, 7, 90 and 180 ]
    quantitative and qualitative analysis of leukocytes in patients with acute media infarct
  • autoantigen-specific T-cells in patients with acute media infarct [ Time Frame: within 36 h, after day 3, 7, 90 and 180 ]
    quantitative determination of autoantigen-specific T-cells in patients with acute media infarct
Complete list of historical versions of study NCT01082783 on ClinicalTrials.gov Archive Site
  • frequency and phenotype of CNS-autoreactive immune cells under the influence of immunodepression [ Time Frame: within 36 h, after day 3, 7, 90 and 180 ]
  • clinical course, i.e. mortality and prognosis (measured by mod. Rankin Scale) [ Time Frame: after day 90 and 180 ]
  • clinical course, i.e. mortality and prognosis (measured by Bartel Index) [ Time Frame: after day 90 and 180 ]
  • frequency and phenotype of CNS-autoreactive immune cells [ Time Frame: within 36 h, after day 3, 7, 90 and 180 ]
    frequency and phenotype of CNS-autoreactive immune cells
  • clinical course, i.e. mortality and prognosis [ Time Frame: after day 90 and 180 ]
    clinical course, i.e. mortality and prognosis
Not Provided
Not Provided
 
Autoimmune Phenomena After Acute Stroke
Autoimmune Phenomena After Acute Stroke - the Role of Stroke-induced Immunodepression

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.

Not Provided
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
blood samples (serum and plasma)
Probability Sample
acute media infarct or intracerebral bleeding
Stroke
Not Provided
  • patients with acute media infarct
  • controls with cardiovascular risks
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
November 2011
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01082783
ARIMIS
No
Not Provided
Not Provided
Andreas Meisel, Charite University, Berlin, Germany
Charite University, Berlin, Germany
NeuroCure Clinical Research Center, Charite, Berlin
Principal Investigator: Andreas Meisel, MD Charite University, Berlin, Germany
Charite University, Berlin, Germany
June 2017