Study of Inflammatory Cells in the Blood and Cerebral Thrombus of Patients Affected by Cerebral Ischemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stroke Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Insights Into Cerebral Clot Biomarkers and Inflammatory Pathways
Overview
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.
Primary outcome measures
- Quantification of leukocyte Infiltration in Thrombus [Time frame: 01.07.2025 up to 06.05.2030]
- Assess the number of neutrophil extracellular traps (NETS) [Time frame: from 6/2025 to 5/2030]
Secondary outcome measures (2)
- Quantitative Analysis of Red Blood Cells, Fibrin, von Willebrand Factor, and Platelets in Thrombus. [Time frame: 01.08.2025 - 01-05-2030]
- Quantification of Plasma Cytokine Levels in Ischemic Stroke Patients [Time frame: 01.08.2025 - 01.05.2030]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Neurology — Milan
Identifiers
NCT: NCT07033988 · CET 96-2025