NCT03746964

Brief Summary

The biomechanical properties of the aorta are currently poorly understood. A better understanding would optimize surgical indications and monitoring techniques for patients with thoracic aortic aneurysms.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Dec 2018

Longer than P75 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 Progress91%
Dec 2018Feb 2027

First Submitted

Initial submission to the registry

November 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

December 17, 2018

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

8 years

First QC Date

November 16, 2018

Last Update Submit

January 8, 2026

Conditions

Patient With Ascending Aortic Aneurysm With Surgical Indication for Replacement

Outcome Measures

Primary Outcomes (2)

  • aortic compliance by cardiac MRI

    Before surgery

  • In-vitro testing of the elasticity of the aortic wall fragment collected during surgery.

    through study completion, an average of 12 months

Interventions

Cardiac MRIPROCEDURE

Preoperative cardiac MRI

in-vitro elasticity testsOTHER

in-vitro elasticity tests performed on a segment of ascending aorta collected during surgery

Eligibility Criteria

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

Patient in preoperative consultation in the cardiovascular and thoracic surgery department.

You may qualify if:

  • Person who has given oral consent
  • Patient with ascending aortic aneurysm with surgical indication for replacement
  • Age \> 18 years old
  • Scheduled surgery

You may not qualify if:

  • Person not affiliated to the national health insurance system
  • Protected adult
  • Pregnant or breastfeeding woman
  • MRI Contraindication
  • Emergency surgical procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

RECRUITING

Central Study Contacts

Comlan BLITTI

CONTACT

+33 3 80 29 33 52comlanmawuko.blitti@chu-dijon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 20, 2018

Study Start

December 17, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

FR(1)