NCT07695545

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
37mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Aug 2029

Study Start

First participant enrolled

June 28, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

3.1 years

First QC Date

July 6, 2026

Last Update Submit

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)

Procedure: Additional blood samplesProcedure: Collection of discarded ascending aortic tissue

Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV)

Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV)

Procedure: Additional blood samplesProcedure: Collection of discarded ascending aortic tissue

Interventions

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

Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV)Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV)

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.

Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV)Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Aneurysm, Ascending Aorta

Condition Hierarchy (Ancestors)

Aortic Aneurysm, ThoracicAortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

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

Locations