Epicardial Fat Immunity extRa Cellular vesicleS HearT
ConditionCardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAssistance Publique Hopitaux De Marseille
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Epicardial adipose tissue biopsy
Procedure/SurgeryBiopsy of epicardial adipose tissue is performed during cardiac surgery following sternotomy and immediately before the establishment of extracorporeal circulation.
Thoracic subcutaneous adipose tissue biopsy
Procedure/SurgeryBiopsy of thoracic subcutaneous adipose tissue is performed during cardiac surgery following sternotomy and immediately before the establishment of extracorporeal circulation.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Patients undergoing cardiac surgeryExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Effect of epicardial and subcutaneous adipose tissue-derived extracellular vesicles on inflammatory and beiging-related gene and protein expression
Comparison of the biological effects of extracellular vesicles (EVs) isolated from epicardial adipose tissue (EAT) versus thoracic subcutaneous adipose tissue (SAT) collected from adult and pediatric patients undergoing cardiac surgery. Functional assessment will be performed in human multipotent adipose-derived stem (hMADS) cells and monocyte-derived macrophages to evaluate changes in the expression of genes and proteins involved in inflammatory pathways and adipocyte beiging.
Time frame
Cardiac surgerySecondary outcomes
1
Characterization of adipokines in epicardial versus subcutaneous adipose tissue assessed by adipokines arrays.
Comparison of the profile and quality of adipokine secretion between EVs isolated from epicardial adipose tissue (EAT) and thoracic subcutaneous adipose tissue (TSAT).
Time frame
Cardiac surgery2
Characterization of extracellular vesicle lipid composition, plasmalogen content, and metabolomic profile in epicardial versus subcutaneous adipose tissue assessed by mass spectrometry
Comparison of the profile and quality of extracellular vesicle (EV) lipid composition, plasmalogen content, and metabolomic signatures between EVs isolated from epicardial adipose tissue (EAT) and thoracic subcutaneous adipose tissue (TSAT).
Time frame
Cardiac surgery3
Beiging-inducing and inflammatory potential of extracellular vesicles derived from epicardial versus subcutaneous adipose tissue assessed by RT-PCR and western blot.
Functional assessment of EVs isolated from EAT and TSAT to determine their capacity to induce beiging in human multipotent adipose-derived stem (hMADS) cells and to modulate the phenotype of monocyte-derived macrophages (MoDM). Macrophage polarization toward pro-inflammatory or anti-inflammatory profiles will be evaluated following exposure to EVs from the different adipose tissue depots.
Time frame
Cardiac surgery4
Association between pericoronary adipose tissue inflammation assessed by coronary CT and extracellular vesicle characteristics
Evaluation of the relationship between pericoronary adipose tissue inflammation measured by coronary computed tomography (CT) imaging and the biological characteristics of EVs isolated from epicardial adipose tissue, including adipokine profile, lipid composition, plasmalogen content, and metabolomic signatures.
Time frame
Coronary CT performed preoperatively; EV characterization performed on tissue samples collected during cardiac surgery.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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