Characterization of Exosomes Platelets-released

Recruiting

• Conditions: Platelet Thrombus

• Registration Number: NCT06298682
• Lead Sponsor: Centro Cardiologico Monzino

Brief Summary

Extracellular vesicles (EVs) play a key role in cell-to-cell communication. They are small vesicles that contain rich molecular cargo. Recently, they have been proposed as biomarkers for clinical diagnostics. EVs include three classes: small EVs (exosomes), large EVs (microparticles), and apoptotic bodies. Platelet-derived EVs (PEVs) are the most abundant class in human blood and can actively participate in numerous physiological and pathological processes. The information about the role of platelet exosomes in cardiovascular disease and the effect of antiplatelet agents on their release and content is very limited.

Detailed Description

This study is a multicentre, observational. We plan to enrol 54 subjects from Centro Cardiologico Monzino IRCCS, and 121 buffy coat related to 121 subjects from Centro Trasfusionale Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. biographical and anthropomorphic data will be recorded, a fasting blood venous sample (from ante-cubital vein) will be collected for the haematochemical analyses and for research samples.

Study Timeline

• Study Start: 2021-07-08
• Status Verified: 2024-02
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-07
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-12
• Primary Completion: 2026-07-07
• Study Completion: 2027-07-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• subjects without known pathologies

Exclusion Criteria

• individuals with gastrointestinal diseases,
• individuals with history of hepatic diseases,
• individuals with history of urogenital diseases,
• individuals with history of hematological diseases,
• individuals with history of immunological diseases,
• individuals with history of renal diseases,
• individuals with history of metabolic diseases
• individuals with history of respiratory diseases
• individuals with history of cancer
• individuals with history of cardiovascular disease
• individuals having permanent organ damage
• individuals with major trauma in the last 6 months prior to enrollment
• individuals with surgery in the last 6 months prior to enrollment
• individuals taking medication in the 15 days prior to enrolment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis	36 month
Characterization of exosomes released by activated platelet and exposed to platelet inhibitors by NTA and proteoma analysis	36 month

Secondary Outcome Measures

Name	Time	Method
Platelet exosome profile emerged by NTA and proteoma analysis will be related with the "biographical" and "anthropometric" data of the subjects.	40 month

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy