Inflammatory faCtors AfteR acUte Ischemic Stroke

NCT04412187 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-04-04

No results posted yet for this 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.

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04412187 on ClinicalTrials.gov