Inflammatory faCtors AfteR acUte Ischemic Stroke

NCT04412187 | Recruiting

• 1 other identifier: 19-428
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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

Ischemic Stroke

Keywords

microglia; neuroinflammation; functional outcome after stroke

Outcome Measures

Primary Outcomes (10)

• microglia activation in patients with acute stroke

  Microglia activation will be assessed using TSPO PET imgaing.

  within 10 days after acute ischemic stroke

• microglia activation in patients with acute stroke

  Microglia activation will be assessed using TSPO PET imgaing.

  3 months after acute ischemic stroke

• functional outcome in patients after acute ischemic stroke

  Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.

  3 weeks after acute ischemic stroke

• functional outcome in patients after acute ischemic stroke

  Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.

  3 months after acute ischemic stroke

• functional outcome in patients after acute ischemic stroke

  Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.

  6 months after acute ischemic stroke

• functional outcome in patients after acute ischemic stroke

  Functional outcome measured by the modified Rankin Score (mRS) will be assessed and related to microglial activation.

  12 months after acute ischemic stroke

• cognitive outcome in patients after acute ischemic stroke

  Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.

  3 weeks after acute ischemic stroke

• cognitive outcome in patients after acute ischemic stroke

  Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.

  3 months after acute ischemic stroke

• cognitive outcome in patients after acute ischemic stroke

  Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.

  6 months after acute ischemic stroke

• cognitive outcome in patients after acute ischemic stroke

  Functional outcome in terms of cognition will be assessed by the Montreal Cognitive Assessment (MoCA) and related to microglial activation.

  12 months after acute ischemic stroke

Secondary Outcomes (5)

• inflammatory markers in blood

  3 weeks after acute ischemic stroke

• inflammatory markers in blood

  3 months after acute ischemic stroke

• Duplex ultrasound

  6 months after acute ischemic stroke

• 3T MR imaging

  3 months after acute ischemic stroke

• 3T MR imaging

  12 months after acute ischemic stroke

Study Arms (1)

TSPO PET imaging

OTHER

All study participants will receive \[18F\]-GE-180, i.e. TSPO PET imaging to assess microglia activation.

Diagnostic Test: [18F]-GE-180 PET; Diagnostic Test: 3T MRI; Diagnostic Test: immune cell profiling in blood

Interventions

[18F]-GE-180 PET DIAGNOSTIC_TEST

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

Also known as: TSPO PET imaging

TSPO PET imaging

3T MRI DIAGNOSTIC_TEST

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

TSPO PET imaging

immune cell profiling in blood DIAGNOSTIC_TEST

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

TSPO PET imaging

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Martin Dichgans: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Hospital Muenster: collaborator

Study Sites (2)

Insitute for Stroke and Dementia Research

Munich, Germany, 81377, Germany

RECRUITING

Department of Nuclear Medicine

Munich, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Neuroinflammatory Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Martin Dichgans, Prof.

  LMU Munich

  PRINCIPAL INVESTIGATOR

• Peter Bartenstein, Prof.

  LMU Munich

  PRINCIPAL INVESTIGATOR

• Sibylle Ziegler, Prof.

  LMU Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Dichgans, Prof.

CONTACT

+49 4400; martin.dichgans@med.uni-muenchen.de

Anna Kopczak, MD

CONTACT

+49 4400; anna.kopczak@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Martin Dichgans

Model Details: 18 patients with cortical stroke and 18 patients with subcortical stroke

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 2, 2020
• Study Start: July 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

DE (2)