A 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.

Официальное название

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.

Обзор

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.

Вмешательства

• Процедура Additional blood samples
  Additional blood sample are collected at the time of routine clinical blood sampling for recherche analyses.
• Процедура Collection of discarded ascending aortic tissue
  The aneurysmal portion of the ascending aorta (surgical specimen), which would otherwise be discarded, is collected for research purposes. No other tissue is collected, and the research protocol does not alter the surgical procedure.

Первичные конечные точки

• Inflammatory, metabolic, and transcriptomic markers of myeloid cells and aortic tissue [Срок оценки: At the time of surgery]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Chu Dijon Bourgogne — Dijon

Идентификаторы

NCT: NCT07695545 · BLITTI 2026-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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