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