Characterization of Exosomes Platelets-released

NCT06298682 | Recruiting

• 1 other identifier: CCM1421
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Thrombus

Keywords

exosomes, platelet activation, platelet inhibitors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Platelet exosome profile emerged by NTA and proteoma analysis will be related with the "biographical" and "anthropometric" data of the subjects.

  40 month

Study Arms (1)

subjects without known pathologies

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

subjects without known pathologies

You may qualify if:

• subjects without known pathologies

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, and platelets

Central Study Contacts

Silvia S Barbieri, PhD

CONTACT

0258002021; silvia.barbieri@ccfm.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: July 8, 2021
• Primary Completion (Estimated): July 7, 2026
• Study Completion (Estimated): July 7, 2027
• Last Updated: March 12, 2024

Record last verified: 2024-02

Locations

IT (1)