Characterization of Exosomes Platelets-released
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Platelet Thrombus. Basic parameters: 20 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis [Time frame: 36 month]
- Characterization of exosomes released by activated platelet and exposed to platelet inhibitors by NTA and proteoma analysis [Time frame: 36 month]
Secondary outcome measures (1)
- Platelet exosome profile emerged by NTA and proteoma analysis will be related with the "biographical" and "anthropometric" data of the subjects. [Time frame: 40 month]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
Identifiers
NCT: NCT06298682 · CCM1421