Ischemic StrokeICARUSNCT04412187
Inflammatory faCtors AfteR acUte Ischemic Stroke
A study testing [18F]-GE-180 PET, 3T MRI and immune cell profiling in blood in people with Ischemic Stroke, run by Martin Dichgans at 2 sites in Germany.
Trial summary
ICARUS is an interventional single-centre hospital-based cohort study in patients admitted to the stroke unit with an acute ischemic stroke. The aims of the study are to i) define the characteristics and determinants of microglial activation after human stroke, and ii) assess the correlation of microglial activation… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- [18F]-GE-180 PET, 3T MRI and immune cell profiling in blood
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jul 2020to 31 Dec 2027
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- Acute ischemic stroke (time frame: <72 hours) as defined by an acute focal neurological deficit in combination with a corresponding infarct as documented by a diffusion weighted imaging (DWI)-positive lesion on magnetic resonance imaging (MRI); presence of an infarct involving the cortex or a strictly subcortical infarct
- Written informed consent prior to study participation
- Willingness to participate in study assessments including follow-up
Who cannot join
- Unwillingness or inability to give written consent
- Prior history of stroke, multiple infarcts, infratentorial infarcts affecting the brain stem or cerebellum
- Known diseases of the CNS other than stroke
- Immunomodulatory therapies within the last 3 months prior stroke
- Chronic inflammatory disease
- Infectious diseases within the last 7 days prior stroke
Show all 11Show fewer
- Conditions interfering with follow-up such as end-stage malignancy
- Contraindications for MRI or PET (pacemaker, aneurysm clip, cochlear implant etc.)
- Radiation exposure of > 10mSv per year
- Pregnant or breastfeeding women
- Participation in a clinical trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Insitute for Stroke and Dementia Research
Munich, Germany, 81377
Martin Dichgans, Prof., +49 89 4400 ext. 46019
Anna Kopczak, MD, +49 89 4400 ext. 46125
- Recruiting
Department of Nuclear Medicine
Munich, 81377
Peter Bartenstein, Prof., +49 89 4400 ext. 77646, peter.bartenstein@med.uni-muenchen.de
Matthias Brendel, MD, +49 89 4400 ext. 74646, matthias.brendel@med.uni-muenchen.de
About this study
ICARUS is an interventional single-centre hospital-based cohort study in patients admitted to the stroke unit with an acute ischemic stroke. The aims of the study are to i) define the characteristics and determinants of microglial activation after human stroke, and ii) assess the correlation of microglial activation with circulating inflammatory markers, structural brain changes on neuroimaging, and neurological outcomes.
ICARUS involves serial TSPO-PET imaging along with serial MRI, immune cell profiling in blood, and both clinical and laboratory assessments in 36 patients with acute ischemic stroke caused by a cortical (N=18) or strictly subcortical (N=18) infarct.
In a substudy, the investigators will include 10 independently recruited patients with acute ischemic stroke to assess MRI arterial spin labelling (ASL) sequences as a marker for perfusion measurement of the TSPO tracer.
Read the detailed description
The neuroinflammatory response after ischemic brain injury has been identified as a pathomechanism in ischemic stroke. Stroke induces an activation of microglia in the brain, which lasts over months. However, the characteristics and mechanisms of this microglia activation are insufficiently defined.
Our study hypotheses are (i) that a subpopulation of patients with acute stroke develop prominent microglial activation, and (ii) that patients with extensive microglial activation are more likely to experience poor outcome.
Against this background, the investigators set up the "Inflammatory faCtors AfteR acUte ischemic Stroke (ICARUS)" study as an interventional single-centre hospital-based cohort study. N=36 patients with a cortical (N=18) or strictly subcortical (N=18) acute ischemic stroke will be recruited through the local stroke unit (Department of Neurology, LMU Munich). Study participation involves serial TSPO-PET imaging along with serial MR imaging, immune cell profiling in blood, and both clinical and laboratory assessments. Follow-up assessments at 3 weeks, 3 months, 6 months and 12 months will be conducted at the Institute for Stroke and Dementia Research (ISD) and at the Department of Nuclear medicine, both LMU Munich.
In a substudy, the investigators will include 10 independently recruited patients with acute ischemic stroke to assess MRI arterial spin labelling (ASL) sequences as a marker for perfusion measurement of the TSPO tracer. These patients will receive dynamic PET in addition to the ASL sequences.
- Conditions
- Ischemic Stroke
- Being tested
- [18F]-GE-180 PET, 3T MRI, immune cell profiling in blood
- Keywords
- microglia, neuroinflammation, functional outcome after stroke
- Medical subject headings
- Ischemic Stroke, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-GE-180 PETDiagnostic test
Also called TSPO PET imaging
serial [18F]-GE-180 PET imaging to assess microglia activation
3T MRIDiagnostic test
serial MR imaging (i) to determine infarct characteristics, (ii) to identify gray and white matter structures connected to the infarct, (iii) to detect incident lesions, and (iv) to quantify longitudinal changes e.g. of cortical thickness
immune cell profiling in bloodDiagnostic test
Cell-specific cytokine profiles, markers of activation, terminal differentiation as well as cytotoxicity will be assesses using flow cytometry.
| Study group | Role | What they receive |
|---|---|---|
| TSPO PET imaging | Other | All study participants will receive [18F]-GE-180, i.e. TSPO PET imaging to assess microglia activation. Receives: Diagnostic Test: [18F]-GE-180 PET; Diagnostic Test: 3T MRI; Diagnostic Test: immune cell profiling in blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
microglia activation in patients with acute stroke
Microglia activation will be assessed using TSPO PET imgaing.
Measured: within 10 days after acute ischemic stroke
microglia activation in patients with acute stroke
Microglia activation will be assessed using TSPO PET imgaing.
Measured: 3 months after acute ischemic stroke
functional outcome in patients after acute ischemic stroke
Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.
Measured: 3 weeks after acute ischemic stroke
functional outcome in patients after acute ischemic stroke
Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.
Measured: 3 months after acute ischemic stroke
functional outcome in patients after acute ischemic stroke
Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.
Measured: 6 months after acute ischemic stroke
functional outcome in patients after acute ischemic stroke
Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.
Measured: 12 months after acute ischemic stroke
cognitive outcome in patients after acute ischemic stroke
Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.
Measured: 3 weeks after acute ischemic stroke
cognitive outcome in patients after acute ischemic stroke
Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.
Measured: 3 months after acute ischemic stroke
cognitive outcome in patients after acute ischemic stroke
Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.
Measured: 6 months after acute ischemic stroke
cognitive outcome in patients after acute ischemic stroke
Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.
Measured: 12 months after acute ischemic stroke
Secondary outcomes (5)
inflammatory markers in blood
Inflammatory markers in blood will be assessed by flow cytometry and related to microglial activation.
Measured: 3 weeks after acute ischemic stroke
inflammatory markers in blood
Inflammatory markers in blood will be assessed by flow cytometry and related to microglial activation.
Measured: 3 months after acute ischemic stroke
Duplex ultrasound
Duplex ultrasound will be performed to assess potential progress of atherosclerosis related to inflammatory markers
Measured: 6 months after acute ischemic stroke
3T MR imaging
3T MRI will be performed to relate infarct evolution, secondary neurodegeneration, and stroke outcome to microglial activation.
Measured: 3 months after acute ischemic stroke
3T MR imaging
3T MRI will be performed to relate infarct evolution, secondary neurodegeneration, and stroke outcome to microglial activation.
Measured: 12 months after acute ischemic stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 18 patients with cortical stroke and 18 patients with subcortical stroke
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin Dichgans
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University Hospital Muenster
- Responsible party
- Sponsor-investigator, Martin Dichgans, Ludwig-Maximilians - University of Munich
- Investigators
- Martin Dichgans, Prof., Principal investigator, LMU MunichPeter Bartenstein, Prof., Principal investigator, LMU MunichSibylle Ziegler, Prof., Principal investigator, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412187
- Sponsor's protocol ID
- 19-428
- Acronym
- ICARUS
- Status last verified
- Apr 2025
- First submitted
- 22 May 2020
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory faCtors AfteR acUte Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04412187
- Acronym / sponsor ID
- ICARUS / 19-428
- Conditions
- Ischemic Stroke
- Keywords
- microglia, neuroinflammation, functional outcome after stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Martin DichgansUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University Hospital Muenster
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jun 2020 (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.
ICARUS is an interventional single-centre hospital-based cohort study in patients admitted to the stroke unit with an acute ischemic stroke. The aims of the study are to i) define the characteristics and determinants of microglial activation after human stroke, and ii) assess the correlation of microglial activation with circulating inflammatory markers, structural brain changes on neuroimaging, and neurological outcomes.
ICARUS involves serial TSPO-PET imaging along with serial MRI, immune cell profiling in blood, and both clinical and laboratory assessments in 36 patients with acute ischemic stroke caused by a cortical (N=18) or strictly subcortical (N=18) infarct.
In a substudy, the investigators will include 10 independently recruited patients with acute ischemic stroke to assess MRI arterial spin labelling (ASL) sequences as a marker for perfusion measurement of the TSPO tracer.
Detailed description
The neuroinflammatory response after ischemic brain injury has been identified as a pathomechanism in ischemic stroke. Stroke induces an activation of microglia in the brain, which lasts over months. However, the characteristics and mechanisms of this microglia activation are insufficiently defined.
Our study hypotheses are (i) that a subpopulation of patients with acute stroke develop prominent microglial activation, and (ii) that patients with extensive microglial activation are more likely to experience poor outcome.
Against this background, the investigators set up the "Inflammatory faCtors AfteR acUte ischemic Stroke (ICARUS)" study as an interventional single-centre hospital-based cohort study. N=36 patients with a cortical (N=18) or strictly subcortical (N=18) acute ischemic stroke will be recruited through the local stroke unit (Department of Neurology, LMU Munich). Study participation involves serial TSPO-PET imaging along with serial MR imaging, immune cell profiling in blood, and both clinical and laboratory assessments. Follow-up assessments at 3 weeks, 3 months, 6 months and 12 months will be conducted at the Institute for Stroke and Dementia Research (ISD) and at the Department of Nuclear medicine, both LMU Munich.
In a substudy, the investigators will include 10 independently recruited patients with acute ischemic stroke to assess MRI arterial spin labelling (ASL) sequences as a marker for perfusion measurement of the TSPO tracer. These patients will receive dynamic PET in addition to the ASL sequences.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 18 patients with cortical stroke and 18 patients with subcortical stroke
| Arm | Type | Receives |
|---|---|---|
| TSPO PET imaging | Other | Diagnostic Test: [18F]-GE-180 PET, Diagnostic Test: 3T MRI, Diagnostic Test: immune cell profiling in bloodAll study participants will receive [18F]-GE-180, i.e. TSPO PET imaging to assess microglia activation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 50 years
- Acute ischemic stroke (time frame: <72 hours) as defined by an acute focal neurological deficit in combination with a corresponding infarct as documented by a diffusion weighted imaging (DWI)-positive lesion on magnetic resonance imaging (MRI); presence of an infarct involving the cortex or a strictly subcortical infarct
- Written informed consent prior to study participation
- Willingness to participate in study assessments including follow-up
Key exclusion criteria (11 listed)
- Unwillingness or inability to give written consent
- Prior history of stroke, multiple infarcts, infratentorial infarcts affecting the brain stem or cerebellum
- Known diseases of the CNS other than stroke
- Immunomodulatory therapies within the last 3 months prior stroke
- Chronic inflammatory disease
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 |
|---|---|---|
| [18F]-GE-180 PETAlso: TSPO PET imagingserial [18F]-GE-180 PET imaging to assess microglia activation | Diagnostic test | TSPO PET imaging |
| 3T MRIserial MR imaging (i) to determine infarct characteristics, (ii) to identify gray and white matter structures connected to the infarct, (iii) to detect incident lesions, and (iv) to quantify longitudinal changes e.g. of cortical thickness | Diagnostic test | TSPO PET imaging |
| immune cell profiling in bloodCell-specific cytokine profiles, markers of activation, terminal differentiation as well as cytotoxicity will be assesses using flow cytometry. | Diagnostic test | TSPO PET imaging |
Primary outcome
microglia activation in patients with acute stroke
Time frame: within 10 days after acute ischemic stroke
Microglia activation will be assessed using TSPO PET imgaing.
microglia activation in patients with acute stroke
Time frame: 3 months after acute ischemic stroke
Microglia activation will be assessed using TSPO PET imgaing.
functional outcome in patients after acute ischemic stroke
Time frame: 3 weeks after acute ischemic stroke
Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.
functional outcome in patients after acute ischemic stroke
Time frame: 3 months after acute ischemic stroke
Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.
functional outcome in patients after acute ischemic stroke
Time frame: 6 months after acute ischemic stroke
Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.
functional outcome in patients after acute ischemic stroke
Time frame: 12 months after acute ischemic stroke
Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.
cognitive outcome in patients after acute ischemic stroke
Time frame: 3 weeks after acute ischemic stroke
Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.
cognitive outcome in patients after acute ischemic stroke
Time frame: 3 months after acute ischemic stroke
Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.
cognitive outcome in patients after acute ischemic stroke
Time frame: 6 months after acute ischemic stroke
Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.
cognitive outcome in patients after acute ischemic stroke
Time frame: 12 months after acute ischemic stroke
Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.
5 secondary outcomes
inflammatory markers in blood
Time frame: 3 weeks after acute ischemic stroke
inflammatory markers in blood
Time frame: 3 months after acute ischemic stroke
Duplex ultrasound
Time frame: 6 months after acute ischemic stroke
3T MR imaging
Time frame: 3 months after acute ischemic stroke
3T MR imaging
Time frame: 12 months after acute ischemic stroke
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 4 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Martin Dichgans, Prof. principal investigator
LMU Munich
Peter Bartenstein, Prof. principal investigator
LMU Munich
Sibylle Ziegler, Prof. principal investigator
LMU Munich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]-GE-180 PET, 3T MRI and immune cell profiling in blood in people with Ischemic Stroke, run by Martin Dichgans at 2 sites 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Martin Dichgans, Prof. (+49 4400 ext. 46019, martin.dichgans@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microglia activation in patients with acute stroke (time frame: within 10 days after acute ischemic stroke). The study lists 10 primary outcomes in all. 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 4 Apr 2025.