Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07033988

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Quantification of leukocyte Infiltration in Thrombus

    Time frame: 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..

  2. Assess the number of neutrophil extracellular traps (NETS)

    Time frame: 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 outcomes

  1. Quantitative Analysis of Red Blood Cells, Fibrin, von Willebrand Factor, and Platelets in Thrombus.

    Time frame: 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.

  2. Quantification of Plasma Cytokine Levels in Ischemic Stroke Patients

    Time frame: 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.

Other outcomes

  1. Characterization of Circulating and Tissue-Derived Cell Populations

    Time frame: 01.08.2025 - 01.05.2030

    Cellular profiles will be analyzed from peripheral and tissue-derived samples using advanced molecular and analytical techniques. Data will include single- sell level measurements to explore cellular heterogeneity and potential pathological signatures, summarized by relative abundance and classification of major cell populations.

Study contacts

Contact information is provided by the study sponsor or research team.

Principal Investigator

CONTACT

[email protected]

00390226439816

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

  • German Cancer Research Center
  • University of Manchester
  • University of Zurich

Registry information

Official study title

Insights Into Cerebral Clot Biomarkers and Inflammatory Pathways

Acronym: ClotBioInsight

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.