Autoimmune Phenomena After Acute Stroke (ARIMIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01082783
First received: March 8, 2010
Last updated: February 26, 2013
Last verified: February 2013

March 8, 2010
February 26, 2013
December 2009
August 2013   (final data collection date for primary outcome measure)
  • autoantigen-specific T-cells in patients with acute media infarct [ Time Frame: within 36 h ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    quantitative determination of autoantigen-specific T-cells 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 ] [ Designated as safety issue: No ]
    quantitative and qualitative analysis of leukocytes 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 ] [ Designated as safety issue: No ]
  • clinical course, i.e. mortality and prognosis (measured by mod. Rankin Scale) [ Time Frame: after day 90 and 180 ] [ Designated as safety issue: No ]
  • clinical course, i.e. mortality and prognosis (measured by Bartel Index) [ Time Frame: after day 90 and 180 ] [ Designated as safety issue: No ]
  • frequency and phenotype of CNS-autoreactive immune cells [ Time Frame: within 36 h, after day 3, 7, 90 and 180 ] [ Designated as safety issue: No ]
    frequency and phenotype of CNS-autoreactive immune cells
  • clinical course, i.e. mortality and prognosis [ Time Frame: after day 90 and 180 ] [ Designated as safety issue: No ]
    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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
65
August 2013
August 2013   (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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01082783
ARIMIS
No
Prof. Dr. Andreas Meisel, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Andreas Meisel, MD Charite University, Berlin, Germany
Charite University, Berlin, Germany
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP