Epicardial Fat Immunity extRa Cellular vesicleS HearT (FIRST)
7 september 2026 uppdaterad av: Assistance Publique Hopitaux De Marseille
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
100
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Patients undergoing cardiac surgery
Epicardial adipose tissue biopsy and Thoracic subcutaneous adipose tissue biopsy at the time of cardiac surgery.
|
Biopsy of epicardial adipose tissue is performed during cardiac surgery following sternotomy and immediately before the establishment of extracorporeal circulation.
Biopsy of thoracic subcutaneous adipose tissue is performed during cardiac surgery following sternotomy and immediately before the establishment of extracorporeal circulation.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Effect of epicardial and subcutaneous adipose tissue-derived extracellular vesicles on inflammatory and beiging-related gene and protein expression
Tidsram: Cardiac surgery
|
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.
|
Cardiac surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Characterization of adipokines in epicardial versus subcutaneous adipose tissue assessed by adipokines arrays.
Tidsram: Cardiac surgery
|
Comparison of the profile and quality of adipokine secretion between EVs isolated from epicardial adipose tissue (EAT) and thoracic subcutaneous adipose tissue (TSAT).
|
Cardiac surgery
|
|
Characterization of extracellular vesicle lipid composition, plasmalogen content, and metabolomic profile in epicardial versus subcutaneous adipose tissue assessed by mass spectrometry
Tidsram: Cardiac surgery
|
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).
|
Cardiac surgery
|
|
Beiging-inducing and inflammatory potential of extracellular vesicles derived from epicardial versus subcutaneous adipose tissue assessed by RT-PCR and western blot.
Tidsram: Cardiac surgery
|
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.
|
Cardiac surgery
|
|
Association between pericoronary adipose tissue inflammation assessed by coronary CT and extracellular vesicle characteristics
Tidsram: Coronary CT performed preoperatively; EV characterization performed on tissue samples collected during cardiac surgery.
|
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.
|
Coronary CT performed preoperatively; EV characterization performed on tissue samples collected during cardiac surgery.
|
Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 oktober 2026
Primärt slutförande (Beräknad)
1 oktober 2028
Avslutad studie (Beräknad)
1 oktober 2028
Studieregistreringsdatum
Först inskickad
31 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
7 september 2026
Första postat (Faktisk)
14 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-A01674-45
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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