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

NCT ID: NCT07033988

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-30

Study Completion Date

2030-05-31

Brief Summary

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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

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Conditions

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Stroke Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

University of Zurich

OTHER

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role collaborator

German Cancer Research Center

OTHER

Sponsor Role collaborator

Responsible Party

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Bacigaluppi Marco

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Neurology

Milan, , Italy

Site Status

Countries

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Italy

Central Contacts

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Principal Investigator

Role: CONTACT

00390226439816

Facility Contacts

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Neurology Department

Role: primary

00390226432755

Other Identifiers

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CET 96-2025

Identifier Type: -

Identifier Source: org_study_id

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