Inflammatory faCtors AfteR acUte Ischemic Stroke
NCT04412187 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2025-04-04
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.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
[18F]-GE-180 PET
serial \[18F\]-GE-180 PET imaging to assess microglia activation
- DIAGNOSTIC_TEST
-
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
- DIAGNOSTIC_TEST
-
immune cell profiling in blood
Cell-specific cytokine profiles, markers of activation, terminal differentiation as well as cytotoxicity will be assesses using flow cytometry.
Sponsors & Collaborators
-
Universitätsklinikum Hamburg-Eppendorf
collaborator OTHER -
University Hospital Muenster
collaborator OTHER -
Martin Dichgans
lead OTHER
Principal Investigators
-
Martin Dichgans, Prof. · LMU Munich
-
Peter Bartenstein, Prof. · LMU Munich
-
Sibylle Ziegler, Prof. · LMU Munich
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
Countries
- Germany
Study Locations
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