Insights Into Cerebral Clot Biomarkers and Inflammatory Pathways
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 380
- Locations
- 1
- Primary Endpoint
- Assess the number of neutrophil extracellular traps (NETS)
Study Overview
Brief Summary
This is an observational, prospective and retrospective, single-center study of thrombotic material and blood samples obtained from patients undergoing mechanical endovascular thrombectomy for ischemic stroke caused by large vessel occlusion or stenosis.
The overarching aim of this study is to advance the understanding of the pathogenesis of cerebral ischemia and to support the development of novel therapeutic strategies for cerebrovascular disease. Specifically, the research seeks to elucidate the pathophysiological mechanisms involved in thrombus formation and stabilization that lead to ischemic events, identify thrombus compositions associated with distinct stroke etiologies, and determine features predictive of resistance to current intravenous thrombolytic therapies. In addition, the study aims to discover novel therapeutic targets and to identify circulating blood biomarkers indicative of an elevated risk of thrombosis.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years.
- •Presentation to the emergency department with symptoms and/or signs suggestive of:
- •An acute cerebrovascular event
- •Stroke mimics
- •Stroke-related risk factors (e.g., atrial fibrillation, endocarditis, significant internal carotid stenosis, neoplasms, systemic infections)
- •Undergoing one of the following treatments:
- •Mechanical thrombectomy
- •Intravenous thrombolysis
- •Standard medical therapy
- •Provision of informed consent, either:
- •Directly from the conscious patient
- •Via appropriate procedures for unconscious patients
Exclusion Criteria
- •Pregnancy or breastfeeding
- •Presence of a known autoimmune disease that could interfere with the interpretation of biomarker analyses
Outcomes
Primary Outcomes
Assess the number of neutrophil extracellular traps (NETS)
Time Frame: from 6/2025 to 5/2030
NETs will be quantified in thrombus tissue sections using immunofluorescence staining for citrullinated histone H3 and myeloperoxidase (MPO).
Quantification of leukocyte Infiltration in Thrombus
Time Frame: 01.07.2025 up to 06.05.2030
Leukocyte will be quantified in thrombus sections using immunohistochemistry or immunofluorescence staining for neutrophil markers such as CD45, Cd11b, etc..
Secondary Outcomes
- Quantitative Analysis of Red Blood Cells, Fibrin, von Willebrand Factor, and Platelets in Thrombus.(01.08.2025 - 01-05-2030)
- Quantification of Plasma Cytokine Levels in Ischemic Stroke Patients(01.08.2025 - 01.05.2030)
Investigators
Bacigaluppi Marco
Principal Investigator
IRCCS San Raffaele