NCT07817667

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Oct 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

August 31, 2026

Last Update Submit

September 7, 2026

Conditions

Cardiac Surgery

Keywords

Cardiac surgeryObesityCardiovascular diseaseEpicardial adipose tissue

Outcome Measures

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.

    Cardiac surgery

Secondary Outcomes (4)

  • Characterization of adipokines in epicardial versus subcutaneous adipose tissue assessed by adipokines arrays.

    Cardiac surgery

  • Characterization of extracellular vesicle lipid composition, plasmalogen content, and metabolomic profile in epicardial versus subcutaneous adipose tissue assessed by mass spectrometry

    Cardiac surgery

  • Beiging-inducing and inflammatory potential of extracellular vesicles derived from epicardial versus subcutaneous adipose tissue assessed by RT-PCR and western blot.

    Cardiac surgery

  • Association between pericoronary adipose tissue inflammation assessed by coronary CT and extracellular vesicle characteristics

    Coronary CT performed preoperatively; EV characterization performed on tissue samples collected during cardiac surgery.

Study Arms (1)

Patients undergoing cardiac surgery

EXPERIMENTAL

Epicardial adipose tissue biopsy and Thoracic subcutaneous adipose tissue biopsy at the time of cardiac surgery.

Procedure: Epicardial adipose tissue biopsyProcedure: Thoracic subcutaneous adipose tissue biopsy

Interventions

Epicardial adipose tissue biopsyPROCEDURE

Biopsy of epicardial adipose tissue is performed during cardiac surgery following sternotomy and immediately before the establishment of extracorporeal circulation.

Patients undergoing cardiac surgery
Thoracic subcutaneous adipose tissue biopsyPROCEDURE

Biopsy of thoracic subcutaneous adipose tissue is performed during cardiac surgery following sternotomy and immediately before the establishment of extracorporeal circulation.

Patients undergoing cardiac surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityCardiovascular Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 14, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

September 14, 2026

Record last verified: 2026-09