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NCT Number: NCT06298682

Characterization of Exosomes Platelets-released

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.

Recruiting

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Key information

Conditions

Platelet Thrombus

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location status: Recruiting

Location contact

Daniele Prati

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis

    Time frame: 36 month

  2. Characterization of exosomes released by activated platelet and exposed to platelet inhibitors by NTA and proteoma analysis

    Time frame: 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.

    Time frame: 40 month

Study contacts

Contact information is provided by the study sponsor or research team.

Silvia S Barbieri, PhD

CONTACT

[email protected]

0258002021

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Registry information

Acronym: EXOPLT

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Mar 7, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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