Characterization of Exosomes Platelets-released

Platelet Thrombus Clinical Trial

— EXOPLT  

Official title:

Characterization of Exosomes Platelets-released

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298682
• Other study ID #: CCM1421
• Status: Recruiting
• Start date: July 8, 2021
• Est. completion date: July 7, 2027

Study information

• Verified date: February 2024
• Source: Centro Cardiologico Monzino
• Contact: Silvia S Barbieri, PhD
• Phone: 0258002021
• Email: silvia.barbieri[@]ccfm.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: July 7, 2027
• Est. primary completion date: July 7, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Platelet Thrombus
• Thrombosis

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis		36 month
Primary	Characterization of exosomes released by activated platelet and exposed to platelet inhibitors by NTA and proteoma analysis		36 month
Secondary	Platelet exosome profile emerged by NTA and proteoma analysis will be related with the "biographical" and "anthropometric" data of the subjects.		40 month