Autoimmune Phenomena After Acute Stroke

Stroke Clinical Trial

— ARIMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082783
• Other study ID #: ARIMIS
• Status: Completed
• Start date: December 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	NeuroCure Clinical Research Center, Charite, Berlin

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Klehmet J, Hoffmann S, Walter G, Meisel C, Meisel A. Stroke induces specific alteration of T memory compartment controlling auto-reactive CNS antigen-specific T cell responses. J Neurol Sci. 2016 Sep 15;368:77-83. doi: 10.1016/j.jns.2016.06.039. Epub 2016 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	autoantigen-specific T-cells in patients with acute media infarct	quantitative determination of autoantigen-specific T-cells in patients with acute media infarct	within 36 h
Primary	leukocytes in patients with acute media infarct	quantitative and qualitative analysis of leukocytes in patients with acute media infarct	within 36 hours
Secondary	frequency and phenotype of CNS-autoreactive immune cells under the influence of immunodepression		within 36 h, after day 3, 7, 90 and 180
Secondary	clinical course, i.e. mortality and prognosis (measured by mod. Rankin Scale)		after day 90 and 180
Secondary	clinical course, i.e. mortality and prognosis (measured by Bartel Index)		after day 90 and 180