[18F]-GE-180 PET3T MRIimmune cell profiling in blood
[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.
Study 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 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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Primary outcome measure(s)
microglia activation in patients with acute stroke — within 10 days after acute ischemic stroke Microglia activation will be assessed using TSPO PET imgaing.
microglia activation in patients with acute stroke — 3 months after acute ischemic stroke Microglia activation will be assessed using TSPO PET imgaing.
functional outcome in patients after acute ischemic stroke — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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