Cardiac SurgeryFIRSTNCT07817667
Epicardial Fat Immunity extRa Cellular vesicleS HearT
A study testing Epicardial adipose tissue biopsy and Thoracic subcutaneous adipose tissue biopsy in people with Cardiac Surgery, run by Assistance Publique Hopitaux De Marseille.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Epicardial adipose tissue biopsy and Thoracic subcutaneous adipose tissue biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Cardiac Surgery
- Being tested
- Epicardial adipose tissue biopsy, Thoracic subcutaneous adipose tissue biopsy
- Keywords
- Cardiac surgery, Obesity, Cardiovascular disease, Epicardial adipose tissue
- Medical subject headings
- Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicardial adipose tissue biopsyProcedure or surgery
Biopsy of epicardial adipose tissue is performed during cardiac surgery following sternotomy and immediately before the establishment of extracorporeal circulation.
Thoracic subcutaneous adipose tissue biopsyProcedure or surgery
Biopsy of thoracic subcutaneous adipose tissue is performed during cardiac surgery following sternotomy and immediately before the establishment of extracorporeal circulation.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cardiac surgery | Experimental | Epicardial adipose tissue biopsy and Thoracic subcutaneous adipose tissue biopsy at the time of cardiac surgery. Receives: Procedure: Epicardial adipose tissue biopsy; Procedure: Thoracic subcutaneous adipose tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Cardiac surgery
Secondary outcomes (4)
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).
Measured: Cardiac surgery
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).
Measured: Cardiac surgery
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.
Measured: Cardiac surgery
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.
Measured: Coronary CT performed preoperatively; EV characterization performed on tissue samples collected during cardiac surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817667
- Sponsor's protocol ID
- 2025-A01674-45
- Acronym
- FIRST
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Fat Immunity extRa Cellular vesicleS HearT
- ClinicalTrials.gov ID
- NCT07817667
- Acronym / sponsor ID
- FIRST / 2025-A01674-45
- Conditions
- Cardiac Surgery
- Keywords
- Cardiac surgery, Obesity, Cardiovascular disease, Epicardial adipose tissue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cardiac surgery | Experimental | Procedure: Epicardial adipose tissue biopsy, Procedure: Thoracic subcutaneous adipose tissue biopsyEpicardial adipose tissue biopsy and Thoracic subcutaneous adipose tissue biopsy at the time of cardiac surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epicardial adipose tissue biopsyBiopsy of epicardial adipose tissue is performed during cardiac surgery following sternotomy and immediately before the establishment of extracorporeal circulation. | Procedure or surgery | Patients undergoing cardiac surgery |
| Thoracic subcutaneous adipose tissue biopsyBiopsy of thoracic subcutaneous adipose tissue is performed during cardiac surgery following sternotomy and immediately before the establishment of extracorporeal circulation. | Procedure or surgery | Patients undergoing cardiac surgery |
Primary outcome
Effect of epicardial and subcutaneous adipose tissue-derived extracellular vesicles on inflammatory and beiging-related gene and protein expression
Time frame: 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.
4 secondary outcomes
Characterization of adipokines in epicardial versus subcutaneous adipose tissue assessed by adipokines arrays.
Time frame: Cardiac surgery
Characterization of extracellular vesicle lipid composition, plasmalogen content, and metabolomic profile in epicardial versus subcutaneous adipose tissue assessed by mass spectrometry
Time frame: Cardiac surgery
Beiging-inducing and inflammatory potential of extracellular vesicles derived from epicardial versus subcutaneous adipose tissue assessed by RT-PCR and western blot.
Time frame: Cardiac surgery
Association between pericoronary adipose tissue inflammation assessed by coronary CT and extracellular vesicle characteristics
Time frame: Coronary CT performed preoperatively; EV characterization performed on tissue samples collected during cardiac surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Related trials for Cardiac Surgery
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
Not yet recruiting
Randomized Evaluation of Operating Room Extubation After Cardiac Surgery
Cardiac Surgery
Not yet recruitingObservational study
Biomarkers of Postoperative Complications After Cardiac Surgery
Postoperative Complications
Active, not recruitingPhase 2/3
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
Comparative Effectiveness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Epicardial adipose tissue biopsy and Thoracic subcutaneous adipose tissue biopsy in people with Cardiac Surgery, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of epicardial and subcutaneous adipose tissue-derived extracellular vesicles on inflammatory and beiging-related gene and protein expression (time frame: Cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.