Epicardial Fat Immunity extRa Cellular vesicleS HearT (FIRST)
7. september 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. oktober 2028
Studiet fullført (Antatt)
1. oktober 2028
Datoer for studieregistrering
Først innsendt
31. august 2026
Først innsendt som oppfylte QC-kriteriene
7. september 2026
Først lagt ut (Faktiske)
14. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-A01674-45
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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