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OpenTrials
Completed

NCT Number: NCT01082783

Autoimmune Phenomena After Acute Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. clinical course, i.e. mortality and prognosis (measured by mod. Rankin Scale)

    Time frame: after day 90 and 180

  3. clinical course, i.e. mortality and prognosis (measured by Bartel Index)

    Time frame: after day 90 and 180

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • NeuroCure Clinical Research Center, Charite, Berlin

Registry information

Official study title

Autoimmune Phenomena After Acute Stroke - the Role of Stroke-induced Immunodepression

Acronym: ARIMIS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 9, 2010
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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