RecruitingNot ApplicableNCT04412187

Inflammatory faCtors AfteR acUte Ischemic Stroke

Sponsor

Martin Dichgans

Enrollment

36 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

Ischemic Stroke

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

Min Age: 50 Years

Inclusion Criteria4

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 Criteria11

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

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Interventions

DIAGNOSTIC_TEST[18F]-GE-180 PET

serial \[18F\]-GE-180 PET imaging to assess microglia activation

DIAGNOSTIC_TEST3T 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

DIAGNOSTIC_TESTimmune cell profiling in blood

Cell-specific cytokine profiles, markers of activation, terminal differentiation as well as cytotoxicity will be assesses using flow cytometry.