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
  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 Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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


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 ] [ 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 ]

Biospecimen Retention:   Samples Without DNA

blood samples (serum and plasma)


Estimated Enrollment: 65
Study Start Date: December 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with acute media infarct
controls with cardiovascular risks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082783

Locations
Germany
Charite University Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Andreas Meisel, MD Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Prof. Dr. Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01082783     History of Changes
Other Study ID Numbers: ARIMIS
Study First Received: March 8, 2010
Last Updated: February 26, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by 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:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014