Autoimmune Phenomena After Acute Stroke - Tabular View

Tracking Information

First Received Date ^ICMJE

March 8, 2010

Last Updated Date

July 20, 2011

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

autoantigen-specific T-cells in patients with acute media infarct [ Time Frame: within 36 h, after day 3, 7, 90 and 180 ] [ 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 h, after day 3, 7, 90 and 180 ] [ Designated as safety issue: No ]
quantitative and qualitative analysis of leukocytes in patients with acute media infarct

Change History

Complete list of historical versions of study NCT01082783 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
frequency and phenotype of CNS-autoreactive immune cells under the influence of immunodepression
clinical course, i.e. mortality and prognosis [ Time Frame: after day 90 and 180 ] [ Designated as safety issue: No ]
clinical course, i.e. mortality and prognosis

Original Secondary Outcome Measures ^ICMJE

frequency and phenotype of CNS-autoreactive immune cells [ Time Frame: within 36 h, after day 3, 7, 90 and 180 ] [ Designated as safety issue: No ]
frequency and phenotype of CNS-autoreactive immune cells
clinical course, i.e. mortality and prognosis [ Time Frame: after day 90 and 180 ] [ Designated as safety issue: No ]
clinical course, i.e. mortality and prognosis

Descriptive Information

Brief Title ^ICMJE

Autoimmune Phenomena After Acute Stroke

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Biospecimen

Retention: Samples Without DNA

Description:

blood samples (serum and plasma)

Sampling Method

Probability Sample

Study Population

acute media infarct or intracerebral bleeding

Condition ^ICMJE

Stroke

Intervention ^ICMJE

Comparison Groups

patients with acute media infarct
controls with cardiovascular risks

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Andreas Meisel, MD	+49 30 450 ext 560026	andreas.meisel@charite.de
Contact: Juliane Klehmet, MD	+49 30 450 ext 539724	juliane.klehmet@charite.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01082783

Other Study ID Numbers ^ICMJE

ARIMIS

Has Data Monitoring Committee

Responsible Party

Prof. Dr. Andreas Meisel, Charite University, Berlin, Germany

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Andreas Meisel, MD

Charite University Berlin

Information Provided By

Charite University, Berlin, Germany

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP