Skip to content

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

Insights Into Cerebral Clot Biomarkers and Inflammatory Pathways

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07033988
Acronym
ClotBioInsight
Enrollment
380
Registered
2025-06-24
Start date
2025-06-30
Completion date
2030-05-31
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Acute

Keywords

stroke, thrombectomy, clot, inflammation, biomarker, pathphysiology

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.

Interventions

None listed

Sponsors

University of Zurich
CollaboratorOTHER
University of Manchester
CollaboratorOTHER
German Cancer Research Center
CollaboratorOTHER
IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quantification of leukocyte Infiltration in Thrombus01.07.2025 up to 06.05.2030Leukocyte will be quantified in thrombus sections using immunohistochemistry or immunofluorescence staining for neutrophil markers such as CD45, Cd11b, etc..
Assess the number of neutrophil extracellular traps (NETS)from 6/2025 to 5/2030NETs will be quantified in thrombus tissue sections using immunofluorescence staining for citrullinated histone H3 and myeloperoxidase (MPO).

Secondary

MeasureTime frameDescription
Quantitative Analysis of Red Blood Cells, Fibrin, von Willebrand Factor, and Platelets in Thrombus.01.08.2025 - 01-05-2030Histological 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.
Quantification of Plasma Cytokine Levels in Ischemic Stroke Patients01.08.2025 - 01.05.2030Plasma 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

MeasureTime frameDescription
Characterization of Circulating and Tissue-Derived Cell Populations01.08.2025 - 01.05.2030Cellular 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.

Countries

Italy

Contacts

Primary ContactPrincipal Investigator
ctc.trialstartup@hsr.it00390226439816

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026