Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2020-07-01
2027-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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TSPO PET imaging
All study participants will receive \[18F\]-GE-180, i.e. TSPO PET imaging to assess microglia activation.
[18F]-GE-180 PET
serial \[18F\]-GE-180 PET imaging to assess microglia activation
3T MRI
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 blood
Cell-specific cytokine profiles, markers of activation, terminal differentiation as well as cytotoxicity will be assesses using flow cytometry.
Interventions
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[18F]-GE-180 PET
serial \[18F\]-GE-180 PET imaging to assess microglia activation
3T MRI
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 blood
Cell-specific cytokine profiles, markers of activation, terminal differentiation as well as cytotoxicity will be assesses using flow cytometry.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
University Hospital Muenster
OTHER
Martin Dichgans
OTHER
Responsible Party
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Martin Dichgans
Prof. Dr. Martin Dichgans
Principal Investigators
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Martin Dichgans, Prof.
Role: PRINCIPAL_INVESTIGATOR
LMU Munich
Peter Bartenstein, Prof.
Role: PRINCIPAL_INVESTIGATOR
LMU Munich
Sibylle Ziegler, Prof.
Role: PRINCIPAL_INVESTIGATOR
LMU Munich
Locations
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Insitute for Stroke and Dementia Research
Munich, Germany, Germany
Department of Nuclear Medicine
Munich, , Germany
Countries
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Central Contacts
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Facility Contacts
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Martin Dichgans, Prof.
Role: primary
Anna Kopczak, MD
Role: backup
Other Identifiers
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19-428
Identifier Type: -
Identifier Source: org_study_id
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