Epicardial Fat Immunity extRa Cellular vesicleS HearT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Effect of epicardial and subcutaneous adipose tissue-derived extracellular vesicles on inflammatory and beiging-related gene and protein expression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients undergoing cardiac surgery
Epicardial adipose tissue biopsy and Thoracic subcutaneous adipose tissue biopsy at the time of cardiac surgery.
干预措施: Epicardial adipose tissue biopsy (Procedure)
Patients undergoing cardiac surgery
Epicardial adipose tissue biopsy and Thoracic subcutaneous adipose tissue biopsy at the time of cardiac surgery.
干预措施: Thoracic subcutaneous adipose tissue biopsy (Procedure)
结局指标
主要结局
Effect of epicardial and subcutaneous adipose tissue-derived extracellular vesicles on inflammatory and beiging-related gene and protein expression
时间窗: 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.
次要结局
- 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.)