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Not Yet Recruiting NCT07817667

Epicardial Fat Immunity extRa Cellular vesicleS HearT

Conditions: Cardiac Surgery

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Assistance Publique Hopitaux De Marseille

Summary

The FIRST study is a monocentric observational pilot study investigating the role of extracellular vesicles (EVs) derived from epicardial adipose tissue (EAT) in cardiovascular complications associated with obesity. EVs isolated from epicardial and subcutaneous adipose tissues obtained during cardiac surgery in adults and children will be analyzed for their molecular composition and biological activity. The study will evaluate their effects on inflammation and adipocyte beiging pathways in hMADS cells and monocyte-derived macrophages, and explore associations between EV characteristics and coronary perivascular inflammation assessed by CT imaging. Findings may improve understanding of the immunometabolic mechanisms linking EAT to cardiovascular disease.

Eligibility Criteria

Inclusion Criteria: * Written informed consent obtained from the patient, parent(s), or legally authorized representative prior to participation. * Adult or pediatric patient. * Scheduled for open-heart cardiac surgery. * Affiliated with or beneficiary of a health insurance system. Exclusion Criteria: * Participation in another clinical research study requiring an exclusion period at the time informed consent is signed. * Individuals belonging to vulnerable populations covered by Articles L1121-5 to L1121-8 of the French Public Health Code, including adults under legal protection (guardianship or curatorship), individuals deprived of liberty, and pregnant or breastfeeding women. * Inability to understand the French language. * Contraindication to cardiac surgery, including uncontrolled sepsis or unstable hemodynamic status.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07817667). StuddyBuddy aggregates publicly available trial information.