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

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Stroke Acute

Study type: Observational

Funder types: Other

Identifiers

NCT07033988

CET 96-2025

Details and patient eligibility

About

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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

380 participants in 1 patient group

Stroke_Patients

Description:

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.