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Extracellular Vesicle Surface Markers In Acute Cerebrovascular Syndromes.

NCT06319742 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-04-18

No results posted yet for this study

Summary

Clinical implication of eventual blood biomarkers for stroke diagnosis and prognosis would be limited, mainly because clinical evaluation and scales (providing stroke severity) or neuroimaging (providing accurate size of the lesion) are more reliable predictors for clinical outcome prediction. In clinical practice, it would be more useful to find a biomarker, which can help to orientate the physician in conditions in which the clinical picture and imaging provide a limited support.

Transient Ischemic Attacks (TIAs) represent a classical example for which a biomarker would be of interest to confirm and distinguish a brain ischemic process from a stroke mimic. Diagnostic biomarkers of TIA have been investigated, but none of the potential candidates reached enough accuracy for TIA diagnosis. Our group has found that Extracellular Vesicles (EVs) could be useful as biomarkers for detecting brain ischemia in patients with TIA because the EV-surface antigen profile appears to be different in patients with transient symptoms, adjudicated to be very likely caused by brain ischemia, compared to patients whose symptoms were less likely to due to brain ischemia. Our study has raised interest in the scientific community recognizing the promising role of of blood-derived EVs analysis in expanding the possibilities to correctly diagnose and classify TIA and stroke events, discriminate them from TIA or stroke mimics, with important future implications in management and therapy of the patients with acute ischemic cerebrovascular syndrome. the validity of our approach needs to be tested in a larger, prospective, multicenter study.

Conditions

  • Stroke, TIA, Stroke-mimics, Stroke Biomarkers

Interventions

DIAGNOSTIC_TEST

Extracellular vescicles (EV) analysis

The patients undergo a blood sample for EV analyses: EVs will be characterized by nanoparticle tracking analysis, western blot, bead-based flow cytometry (direct and inverse approach), and ELISA. We will evaluate diameter and concentration of serum nanoparticles (NPs) by nanoparticle tracking analysis (NTA) using NanoSight LM10. Western Blot analysis will be performed on protein lysate after EV immuno-capture (using beads covered with antibodies against EV specific tetraspanins, CD9, CD63 and CD81). EV profiling will be performed using a standardized multiplex bead-based flow cytometric assay, using MACSPlex Human Exosome Kit (Miltenyi Biotec; Bergisch Gladbach, Germany), as previously described. 22 The detection of 37 different surface antigens commonly expressed on EV membrane (including markers from activated platelets, endothelium, and inflammatory cells) will be simultaneously performed.

Sponsors & Collaborators

  • Ospedale Civico, Lugano

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-18
Primary Completion
2025-12-31
Completion
2026-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06319742 on ClinicalTrials.gov