Epicardial Fat Immunity extRa Cellular vesicleS HearT (FIRST)
7. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
100
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Effect of epicardial and subcutaneous adipose tissue-derived extracellular vesicles on inflammatory and beiging-related gene and protein expression
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Characterization of adipokines in epicardial versus subcutaneous adipose tissue assessed by adipokines arrays.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. oktober 2028
Studieafslutning (Anslået)
1. oktober 2028
Datoer for studieregistrering
Først indsendt
31. august 2026
Først indsendt, der opfyldte QC-kriterier
7. september 2026
Først opslået (Faktiske)
14. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-A01674-45
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