NCT03817008

Brief Summary

The aim of our study was to evaluate the impact of aortic root replacement by a graft on the elastic properties of the descending thoracic aorta using cardiac Magnetic Resonance Imaging (MRI) and automatic post-processing. Nineteen patients were operated on an aortic root aneurysm and a cardiac MRI allowing aortic compliance measurement was performed before and after surgery. Images were acquired with a 1.5 T MRI with only one additional sequence to a conventional aortic MRI protocol.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Status
completed

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

September 1, 2014

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

4.4 years

First QC Date

January 17, 2019

Last Update Submit

January 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Aortic compliance of descending aorta (mm2/mmHg)

    Aortic elastic properties of the descending aorta before and after aortic root replacement using cardiac MRI. Aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processing.

    post-operative cardiac MRI performing between 12 and 24 months

Secondary Outcomes (1)

  • Aortic compliance of ascending aorta (mm2/mmHg)

    post-operative cardiac MRI performing between 12 and 24 months

Interventions

Patient with planned Ascending aorta replacement with graft

Also known as: cardiac MRI

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

19 patients operated in Cardiac Surgery unit of DIJON Hospital between September 2014 and December 2017.

You may qualify if:

  • \> 18 years
  • Elective patient
  • Ascending aorta replacement with graft

You may not qualify if:

  • Prior cardiac surgery
  • Contraindication to performing cardiac MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Morgant MC, Miteran J, Lin S, Laubriet A, Cochet A, Lalande A, Bouchot O. Impact of ascending aorta replacement by graft on elastic properties of descending thoracic aorta evaluated by cardiac magnetic resonance imaging. MAGMA. 2020 Oct;33(5):641-647. doi: 10.1007/s10334-020-00829-5. Epub 2020 Jan 31.

MeSH Terms

Interventions

Transplantation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

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

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 25, 2019

Study Start

September 1, 2014

Primary Completion

January 17, 2019

Study Completion

January 17, 2019

Last Updated

January 25, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share