NCT05252143

Brief Summary

The aim of our study is to assess a correlation between local patient specific elastic modulus distribution of the ascending aorta from a biaxial tensile test and MRI measurements of the elastic properties of the aorta. A total of 70 patients referred for ascending aorta (AA) replacement underwent a preoperative cardiac-MRI for the evaluation the elastic properties and ascending aorta tissue was collected for biaxial testing to obtain maximum elastic modulus

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

December 1, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

3.2 years

First QC Date

February 14, 2022

Last Update Submit

February 14, 2022

Conditions

Compliance, Magnetic Resonance Imaging, Biaxial Testing, Elastic Modulus

Outcome Measures

Primary Outcomes (1)

  • aortic compliance of ascending aorta (mm2/mmHg)

    aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processsing

    preoperative cardiac MRI performing between 1 month and 1 day before surgery

Secondary Outcomes (1)

  • maximum elastic modulus (MPa) of ascending aorta

    biaxial testing performing between 1 and 6 hours after procedure

Eligibility Criteria

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

200 patients operated in cardiac surgery unit of Dijon hospital starting in December 2018

You may qualify if:

  • patient referred for ascending aorta aneurysm requiering replacement
  • elective patient

You may not qualify if:

  • claustrophobia
  • contraindication to performing cardiac MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dijon University Hospital

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

marie-catherine Morgant, MD

CONTACT

33-380293352mariecatherine.morgant@chu-dijon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 14, 2022

First Posted

February 23, 2022

Study Start

December 1, 2018

Primary Completion

February 14, 2022

Study Completion

December 31, 2024

Last Updated

February 23, 2022

Record last verified: 2022-02

Locations

FR(1)