StrokeARIMISNCT01082783
Autoimmune Phenomena After Acute Stroke
An observational study of Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: acute media infarct or intracerebral bleeding
Who may be able to join
- 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)
Who cannot join
- infections (patients, controls)
- antibiotic or immunosuppressive treatment within the last 4 weeks (patients)
- other CNS disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stroke
- Keywords
- stroke-induced immunodepression, acute media infarct, acute intracerebral bleeding, leucocytes, autoaggressive T-cells, acute media infarct or acute intracerebral bleeding
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with acute media infarct | Not described | |
| controls with cardiovascular risks | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
autoantigen-specific T-cells in patients with acute media infarct
quantitative determination of autoantigen-specific T-cells in patients with acute media infarct
Measured: within 36 h
leukocytes in patients with acute media infarct
quantitative and qualitative analysis of leukocytes in patients with acute media infarct
Measured: within 36 hours
Secondary outcomes (3)
frequency and phenotype of CNS-autoreactive immune cells under the influence of immunodepression
Measured: within 36 h, after day 3, 7, 90 and 180
clinical course, i.e. mortality and prognosis (measured by mod. Rankin Scale)
Measured: after day 90 and 180
clinical course, i.e. mortality and prognosis (measured by Bartel Index)
Measured: after day 90 and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startDec 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
- Responsible party
- Principal investigator, Andreas Meisel, Charite University, Berlin, Germany
- Investigators
- Andreas Meisel, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082783
- Sponsor's protocol ID
- ARIMIS
- Acronym
- ARIMIS
- Status last verified
- Nov 2018
- First submitted
- 8 Mar 2010
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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 Jun 17.
PubMed 27538605
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoimmune Phenomena After Acute Stroke - the Role of Stroke-induced Immunodepression
- ClinicalTrials.gov ID
- NCT01082783
- Acronym / sponsor ID
- ARIMIS / ARIMIS
- Conditions
- Stroke
- Keywords
- stroke-induced immunodepression, acute media infarct, acute intracerebral bleeding, leucocytes, autoaggressive T-cells, acute media infarct or acute intracerebral bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
- Study start
- Dec 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with acute media infarct | – | – |
| controls with cardiovascular risks | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- acute media infarct or intracerebral bleeding
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- infections (patients, controls)
- antibiotic or immunosuppressive treatment within the last 4 weeks (patients)
- other CNS disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
leukocytes in patients with acute media infarct
Time frame: within 36 hours
quantitative and qualitative analysis of leukocytes in patients with acute media infarct
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Results publication: PubMed 27538605Klehmet 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 Jun 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Meisel, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
autoantigen-specific T-cells in patients with acute media infarct (time frame: within 36 h). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01082783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.