Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07695545

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.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Ascending Aortic Aneurysm Aneurysm Aneurysm, Ascending Aorta Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Location status: Recruiting

Location contact

Aline LAUBRIET-JAZAYERI

CONTACT

[email protected]

03.80.28.12.94 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Additional blood samples

Procedure

Additional blood sample are collected at the time of routine clinical blood sampling for recherche analyses.

Collection of discarded ascending aortic tissue

Procedure

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.

Primary outcomes

  1. Inflammatory, metabolic, and transcriptomic markers of myeloid cells and aortic tissue

    Time frame: At the time of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Comlan BLITTI

CONTACT

[email protected]

03.80.29.33.52 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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.

Acronym: PROMETA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 10, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.