Clinical trial NCT06298682: Characterization of Exosomes Platelets-released
Official title: Characterization of Exosomes Platelets-released
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Platelet Thrombus
Keywords: exosomes, platelet activation, platelet inhibitors
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2024-03-07
Enrollment: 175
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: subjects without known pathologies

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis
timeFrame: 36 month
measure: Characterization of exosomes released by activated platelet and exposed to platelet inhibitors by NTA and proteoma analysis
timeFrame: 36 month
Secondary outcomes:
measure: Platelet exosome profile emerged by NTA and proteoma analysis will be related with the "biographical" and "anthropometric" data of the subjects.
timeFrame: 40 month
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
References: