StrokeIMMUNOSTROKENCT04701619
Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies (IMMUNOSTROKE)
A study testing Immuno-inflammatory profile description in patients with ischemic stroke in people with Stroke and Ischemic Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
IMMUNOSTROKE study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the course of AIC management by reperfusion treatment and to monitor changes in these different parameters over time. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Ischemic Stroke
- What is being tested?
- Immuno-inflammatory profile description in patients with ischemic stroke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 15 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age
- Presenting with an ACS for which reperfusion therapy is indicated according to European and North American recommendations (IV thrombolysis or mechanical thrombectomy or a combination of both)
- Having received informed information about the study and having signed a consent form to participate in the study (if this is not possible: information and consent from a trusted person or family member if present; emergency inclusion if absent)
- Affiliated with or beneficiary of a social security system
Who cannot join
- Contraindication to performing a brain MRI (claustrophobia, pacemaker, or other implantable device contraindicating the performance of an MRI)
- Intracranial hemorrhage associated with AIC on initial imaging
- Immunosuppressive treatment or corticosteroid therapy at patient admission
- Pre-existing neurological disability limiting neurological assessment at 3 months (mRS>2 at admission)
- Known and diagnosed dementia pre-existing at the time of the AIC
- Absolute or relative contraindication to the injection of gadolinium (history of true allergic reaction or intolerance to gadobutrol, renal failure with creatinine clearance <15mL/min, pregnant or breastfeeding women)
- Patient treated by another institution and referred solely for mechanical thrombectomy
- Patient benefiting from legal protection measures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies
IMMUNOSTROKE study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the course of AIC management by reperfusion treatment and to monitor changes in these different parameters over time. Post-hoc analyses will make it possible to correlate the immuno-inflammatory and thrombo-inflammatory profiles and their evolution with the clinical outcome in terms of post-AIC functional and cognitive disability.
- Conditions
- Stroke, Ischemic Stroke
- Being tested
- Immuno-inflammatory profile description in patients with ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immuno-inflammatory profile description in patients with ischemic strokeOther
Patients will be evaluated for inflammatory biomarkers at inclusion, at 24-48 hours of reperfusion treatment , at 72 hours, at 7 days or at discharge if before D7, at discharge if after D7, at 3 months and at 1 year.The biomarkers will be measured using ELISA panels for inflammatory biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Immuno-inflammatory profile description in patients with ischemic stroke | Other | Patients will be evaluated for inflammatory biomarkers at inclusion, at 24-48 hours of reperfusion treatment , at 72 hours, at 7 days or at discharge if before D7, at discharge if after D7, at 3 months and at 1 year.The biomarkers will be measured using ELISA panels for inflammatory biomarkers Receives: Other: Immuno-inflammatory profile description in patients with ischemic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immuno-inflammatory profile description in patients with ischemic stroke and eligible for reperfusion treatment
Patients will be evaluated for inflammatory biomarkers at inclusion, at 24-48 hours of reperfusion treatment , at 72 hours, at 7 days or at discharge if before D7, at discharge if after D7, at 3 months and at 1 year.The biomarkers will be measured using ELISA preconfigurated panels for inflammatory biomarkers.
Measured: Up to year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start15 Sep 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients undergoing a reperfusion procedure as part of an ischemia stroke will be able to participate in the study.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701619
- Sponsor's protocol ID
- BMR_2020_31
- Acronym
- IMMUNOSTROKE
- Status last verified
- Jan 2026
- First submitted
- 25 Nov 2020
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies
- ClinicalTrials.gov ID
- NCT04701619
- Acronym / sponsor ID
- IMMUNOSTROKE / BMR_2020_31
- Conditions
- Stroke, Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 8 Jan 2021 (actual)
- 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.
IMMUNOSTROKE study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the course of AIC management by reperfusion treatment and to monitor changes in these different parameters over time. Post-hoc analyses will make it possible to correlate the immuno-inflammatory and thrombo-inflammatory profiles and their evolution with the clinical outcome in terms of post-AIC functional and cognitive disability.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients undergoing a reperfusion procedure as part of an ischemia stroke will be able to participate in the study.
| Arm | Type | Receives |
|---|---|---|
| Immuno-inflammatory profile description in patients with ischemic stroke | Other | Other: Immuno-inflammatory profile description in patients with ischemic strokePatients will be evaluated for inflammatory biomarkers at inclusion, at 24-48 hours of reperfusion treatment , at 72 hours, at 7 days or at discharge if before D7, at discharge if after D7, at 3 months and at 1 year.The biomarkers will be measured using ELISA panels for inflammatory biomarkers |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years of age
- Presenting with an ACS for which reperfusion therapy is indicated according to European and North American recommendations (IV thrombolysis or mechanical thrombectomy or a combination of both)
- Having received informed information about the study and having signed a consent form to participate in the study (if this is not possible: information and consent from a trusted person or family member if present; emergency inclusion if absent)
- Affiliated with or beneficiary of a social security system
Key exclusion criteria (8 listed)
- Contraindication to performing a brain MRI (claustrophobia, pacemaker, or other implantable device contraindicating the performance of an MRI)
- Intracranial hemorrhage associated with AIC on initial imaging
- Immunosuppressive treatment or corticosteroid therapy at patient admission
- Pre-existing neurological disability limiting neurological assessment at 3 months (mRS>2 at admission)
- Known and diagnosed dementia pre-existing at the time of the AIC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immuno-inflammatory profile description in patients with ischemic strokePatients will be evaluated for inflammatory biomarkers at inclusion, at 24-48 hours of reperfusion treatment , at 72 hours, at 7 days or at discharge if before D7, at discharge if after D7, at 3 months and at 1 year.The biomarkers will be measured using ELISA panels for inflammatory biomarkers | Other | Immuno-inflammatory profile description in patients with ischemic stroke |
Primary outcome
Immuno-inflammatory profile description in patients with ischemic stroke and eligible for reperfusion treatment
Time frame: Up to year
Patients will be evaluated for inflammatory biomarkers at inclusion, at 24-48 hours of reperfusion treatment , at 72 hours, at 7 days or at discharge if before D7, at discharge if after D7, at 3 months and at 1 year.The biomarkers will be measured using ELISA preconfigurated panels for inflammatory biomarkers.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Immuno-inflammatory profile description in patients with ischemic stroke in people with Stroke and Ischemic Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin MAIER, Professor, MD, PhD (01 48 03 65 56 ext. + 33, bmaier@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immuno-inflammatory profile description in patients with ischemic stroke and eligible for reperfusion treatment (time frame: Up to year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026.