Autoimmune Phenomena After Acute Stroke - Full Text View

Sponsor:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT01082783

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:

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
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

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 ]
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

Biospecimen Retention: Samples Without DNA

blood samples (serum and plasma)

Estimated Enrollment:	50
Study Start Date:	December 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (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:	No
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

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

Contacts

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

Locations

Germany
Charite University Berlin	Recruiting
Berlin, Germany, 10117
Contact: Andreas Meisel, MD +49 30 450 ext 560026 andreas.meisel@charite.de
Contact: Juliane Klehmet, MD +49 30 450 ext 539 734 juliane.klehmet@charite.de
Sub-Investigator: Juliane Klehmet, MD

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:

Andreas Meisel, MD

Charite University Berlin

More Information

No publications provided

Responsible Party:	Charite University, Berlin, Germany ( Prof. Dr. Andreas Meisel )
ClinicalTrials.gov Identifier:	NCT01082783 History of Changes
Other Study ID Numbers:	ARIMIS
Study First Received:	March 8, 2010
Last Updated:	March 12, 2010
Health Authority:	Germany: not applicable as non-interventional

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:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 01, 2010