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

NCT07033988 | Not Yet Recruiting

• 1 other identifier: CET 96-2025
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Acute

Keywords

stroke; thrombectomy; clot; inflammation; biomarker; pathphysiology

Outcome Measures

Primary Outcomes (2)

• Quantification of leukocyte Infiltration in Thrombus

  Leukocyte will be quantified in thrombus sections using immunohistochemistry or immunofluorescence staining for neutrophil markers such as CD45, Cd11b, etc..

  01.07.2025 up to 06.05.2030

• Assess the number of neutrophil extracellular traps (NETS)

  NETs will be quantified in thrombus tissue sections using immunofluorescence staining for citrullinated histone H3 and myeloperoxidase (MPO).

  from 6/2025 to 5/2030

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Characterization of Circulating and Tissue-Derived Cell Populations

  01.08.2025 - 01.05.2030

Study Arms (1)

Stroke_Patients

This cohort includes adult patients diagnosed with acute ischemic stroke due to large vessel occlusion (LVO); subgroups within the cohort may include patients with different etiologies based on standard diagnostic classifications and stratification may be performed by response to thrombolysis, histological thrombus composition, or systemic biomarkers.

Eligibility Criteria

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

Study Population

The study focuses on adult patients experiencing ischemic stroke presenting at the emergency department/ neurology department of the Hospital of inclusion due to a large vessel occlusion and/or stenosis, undergoing standard diagnostic and therapeutic procedures involving mechanical thrombectomy, thrombolysis or standard medical care.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or breastfeeding
• Presence of a known autoimmune disease that could interfere with the interpretation of biomarker analyses

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• University of Zurich: collaborator
• University of Manchester: collaborator
• German Cancer Research Center: collaborator

Study Sites (1)

Neurology

Milan, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cerebral thrombus and blood

MeSH Terms

Conditions

Stroke; Inflammation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Principal Investigator

CONTACT

00390226439816; ctc.trialstartup@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)