A Prospective, Single-center, Open-label Study of Lipid M... | NCT07695545

Studies
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.

NCT07695545

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Recruiting

Last Update Posted

Jul 10, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Ascending Aortic Aneurysm

Interventions

Additional blood samples
Collection of discarded ascending aortic tissue

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2026Actual

Primary Completion Date

Aug 2029Estimated

Completion Date

Aug 2029Estimated

First Submitted Date

Jul 6, 2026

First Submission Date that Met QC Criteria

Jul 6, 2026

First Posted Date

Jul 10, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2026

Last Update Posted Date

Jul 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 samples Procedure: 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 samples Procedure: Collection of discarded ascending aortic tissue

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Additional blood samples	Procedure	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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inflammatory, metabolic, and transcriptomic markers of myeloid cells and aortic tissue		At the time of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with ascending aortic aneurysms

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Comlan BLITTI	Contact	03.80.29.33.52	+33	comlanmawuko.blitti@chu-dijon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Dijon Bourgogne	Recruiting	Dijon		21000	France

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D017545	Aortic Aneurysm, Thoracic
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases