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.
PROMETA
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.
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2026
CompletedFirst Submitted
Initial submission to the registry
July 6, 2026
CompletedFirst Posted
Study publicly available on registry
July 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
July 13, 2026
July 1, 2026
3.1 years
July 6, 2026
July 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Inflammatory, metabolic, and transcriptomic markers of myeloid cells and aortic tissue
At the time of surgery
Study Arms (2)
Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV)
Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV)
Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV)
Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV)
Interventions
Additional blood sample are collected at the time of routine clinical blood sampling for recherche analyses.
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.
Eligibility Criteria
Patients with ascending aortic aneurysms
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Dijon Bourgogne
Dijon, 21000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2026
First Posted
July 10, 2026
Study Start
June 28, 2026
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
August 1, 2029
Last Updated
July 13, 2026
Record last verified: 2026-07