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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
  Purpose

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.


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Autoimmune Phenomena After Acute Stroke - the Role of Stroke-induced Immunodepression

Further study details as provided by Andreas Meisel, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
blood samples (serum and plasma)

Enrollment: 28
Study Start Date: December 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with acute media infarct
controls with cardiovascular risks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
acute media infarct or intracerebral bleeding
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082783


Locations
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
NeuroCure Clinical Research Center, Charite, Berlin
Investigators
Principal Investigator: Andreas Meisel, MD Charite University, Berlin, Germany
  More Information

Publications:
Responsible Party: Andreas Meisel, Professor Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01082783     History of Changes
Other Study ID Numbers: ARIMIS
First Submitted: March 8, 2010
First Posted: March 9, 2010
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Andreas Meisel, Charite University, Berlin, Germany:
stroke-induced immunodepression
acute media infarct
acute intracerebral bleeding
leucocytes
autoaggressive T-cells
acute media infarct or acute intracerebral bleeding

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases