Actively Recruiting

Age: 20Years - 60Years
All Genders
Healthy Volunteers
ID06298682

Characterization of Exosomes Platelets-released

Led by Centro Cardiologico Monzino · Updated on 2024-03-12

175

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

C

Centro Cardiologico Monzino

Lead Sponsor

F

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying platelet-derived extracellular vesicles (PEVs), which are tiny particles released by cells that play important roles in cell communication and may serve as biomarkers for clinical diagnostics. This observational study focuses on understanding the characteristics of platelet exosomes and how antiplatelet agents affect their release and composition, especially in relation to cardiovascular disease. The study is conducted across multiple centers involving healthy adult volunteers without known pathologies. Participants include 54 subjects from one center and 121 buffy coat samples from another. Biographical and body measurement data will be collected along with fasting blood samples drawn from the antecubital vein for hematochemical and research analyses. The primary outcomes involve detailed characterization of exosomes released by activated platelets through nanoparticle tracking analysis and proteomic studies over 36 months. Secondary outcomes will explore how these exosome profiles relate to the participants' demographic and physical data. Throughout the study, participants will undergo blood sampling and data collection to monitor platelet exosome characteristics. Researchers will analyze these samples using advanced laboratory techniques. The study will provide insights into platelet exosome profiles and their possible links to health, with safety ensured by excluding individuals with various diseases or recent medical events. The study will last for up to 40 months, including follow-up analyses of collected data.

CONDITIONS

Brief Title

Characterization of Exosomes Platelets-released

Who Can Participate

Age: 20Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects without known pathologies
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Single timepoint

Participants provide a fasting blood venous sample for haematochemical analyses and research purposes. Biographical and anthropometric data are also recorded.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 40 months

Participants' platelet exosome profiles are characterized and related to their biographical and anthropometric data over time.

No additional visits required for monitoring

Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Actively Recruiting

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Research Team

S

Silvia S Barbieri, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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