Study of Inflammatory Cells in the Blood and Cerebral Thrombus of Patients Affected by Cerebral Ischemia

Not yet recruiting

• Conditions: Stroke Acute

• Registration Number: NCT07033988
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Primary Completion: 2030-05
• Study Completion: 2030-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 380

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantification of leukocyte Infiltration in Thrombus	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..
Assess the number of neutrophil extracellular traps (NETS)	from 6/2025 to 5/2030	NETs will be quantified in thrombus tissue sections using immunofluorescence staining for citrullinated histone H3 and myeloperoxidase (MPO).

Secondary Outcome Measures

Name	Time	Method
Quantitative Analysis of Red Blood Cells, Fibrin, von Willebrand Factor, and Platelets in Thrombus.	01.08.2025 - 01-05-2030	Histological components of the thrombus-including red blood cells (RBCs), fibrin, von Willebrand factor (vWF), and platelets-will be evaluated using immunohistochemistry and immunofluorescence staining. Quantification will be expressed as percentage area fraction (% of total thrombus area) occupied by each component, as assessed by digital image analysis of stained slides.
Quantification of Plasma Cytokine Levels in Ischemic Stroke Patients	01.08.2025 - 01.05.2030	Plasma cytokines will be measured using multiplex immunoassays or ELISA-based methods from peripheral blood samples collected during the acute and subacute phases of ischemic stroke. Concentrations (pg/mL) of cytokines will be quantified and reported as continuous variables to assess systemic inflammatory responses.

Trial Locations

Locations (1)

Neurology; 🇮🇹 Milano, Italy