A Prospective, Single-center, Open-label Study of Lipid Metabolism and Mitochondrial Function in Myeloid Cells and Total Aortic Tissue in Patients With Ascending Thoracic Aortic Aneurysm (ATA) and Bicuspid (BA) or Tricuspid (TA) Aortic Valves.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Inflammatory, metabolic, and transcriptomic markers of myeloid cells and aortic tissue
研究概览
简要总结
Ascending aortic aneurysms (AAAs) are serious conditions that can lead to aortic dissections or ruptures, carrying a high risk of mortality. Their pathophysiology is based on complex mechanisms involving inflammatory and metabolic processes, as well as alterations in mitochondrial function. The presence of a bicuspid aortic valve (BAV) or tricuspid aortic valve (TAV) significantly influences the progression and severity of aneurysms. Bicuspid aortic valve (BAV) patients often develop aortic aneurysms earlier, as early as age 40-50, whereas tricuspid aortic valve (TAV) patients generally present with a degenerative condition that appears later (after age 50). The objective of this study is to compare the inflammatory, metabolic, and transcriptomic signatures of myeloid cells and total aortic tissue between BAV and TAV patients. These analyses will help identify specific molecular mechanisms, potential biomarkers, and therapeutic targets. To ensure pathophysiological homogeneity, patients with aneurysms of genetic origin (Marfan syndrome, Loeys-Dietz syndrome, Ehlers-Danlos syndrome, etc.) will be excluded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who have given their consent
- •Patients with an ascending aortic aneurysm for which surgical replacement is indicated
- •Age > 18 years
- •Scheduled surgery
- •Preoperative ultrasound confirmation of the heart valve architecture (bicuspid or tricuspid valve)
排除标准
- •A person subject to a legal protective measure (guardianship, conservatorship)
- •A person subject to a judicial safeguard measure - A pregnant woman, a woman in labor, or a breastfeeding woman
- •Adults who are legally incapacitated or unable to give consent
- •Emergency surgical procedures
- •Patients with uncontrolled inflammatory or autoimmune conditions
- •Patients with a history of recent acute infection (within the last 3 months or still undergoing treatment)
- •Patients with a condition requiring immunosuppressants - Patients with a confirmed or suspected genetic aneurysm (Marfan syndrome, Loeys-Dietz syndrome, Ehlers-Danlos syndrome, etc.)
- •Patients with a history of cardiac surgery
研究组 & 干预措施
Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV)
Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV)
干预措施: Additional blood samples (Procedure)
Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV)
Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV)
干预措施: Collection of discarded ascending aortic tissue (Procedure)
Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV)
Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV)
干预措施: Additional blood samples (Procedure)
Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV)
Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV)
干预措施: Collection of discarded ascending aortic tissue (Procedure)
结局指标
主要结局
Inflammatory, metabolic, and transcriptomic markers of myeloid cells and aortic tissue
时间窗: At the time of surgery
次要结局
未报告次要终点
