Overview

This trial is active, not recruiting.

Condition stroke
Sponsor Charite University, Berlin, Germany
Start date December 2009
End date August 2013
Trial size 65 participants
Trial identifier NCT01082783, ARIMIS

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm

Primary Outcomes

Measure
autoantigen-specific T-cells in patients with acute media infarct
time frame: within 36 h
leukocytes in patients with acute media infarct
time frame: within 36 hours

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Autoimmune Phenomena After Acute Stroke - the Role of Stroke-induced Immunodepression
Principal investigator Andreas Meisel, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.