Autoimmune Phenomena After Acute Stroke (ARIMIS)

November 28, 2018 updated by: Andreas Meisel, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

acute media infarct or intracerebral bleeding

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
patients with acute media infarct
controls with cardiovascular risks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 36 h
leukocytes in patients with acute media infarct
Time Frame: within 36 hours
quantitative and qualitative analysis of leukocytes in patients with acute media infarct
within 36 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
after day 90 and 180
clinical course, i.e. mortality and prognosis (measured by Bartel Index)
Time Frame: after day 90 and 180
after day 90 and 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

NeuroCure Clinical Research Center, Charite, Berlin

Investigators

  • Principal Investigator: Andreas Meisel, MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARIMIS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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