Characterization of Exosomes Platelets-released (EXOPLT)

March 7, 2024 updated by: Centro Cardiologico Monzino
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
        • Contact:
          • Daniele Prati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

subjects without known pathologies

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
subjects without known pathologies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis
Time Frame: 36 month
36 month
Characterization of exosomes released by activated platelet and exposed to platelet inhibitors by NTA and proteoma analysis
Time Frame: 36 month
36 month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
40 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Cardiologico Monzino

Collaborators

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2021

Primary Completion (Estimated)

July 7, 2026

Study Completion (Estimated)

July 7, 2027

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCM1421

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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