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Changes in Elastic Properties of Descending Thoracic Aorta After Ascending Aorta Replacement

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ClinicalTrials.gov Identifier: NCT03817008
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Collaborators:
JAZAYERI Aline
BOUCHOT Olivier
JAZAYERI Saed
MALAPERT Ghislain
PETROSYAN Andreanik
Information provided by (Responsible Party):
MORGANT Marie-Catherine, Centre Hospitalier La Chartreuse

Study Description
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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.


Condition or disease Intervention/treatment
Aortic Surgery Procedure: Ascending aorta replacement with graft

Detailed Description:

Observational and retrospective trial on medical data only. The patients are operated of planned aortic root aneurysm without additional intervention.

The pre and postoperative cardiac MRI are planned in standard of care.

Study Design
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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Ascending Aorta Replacement by Graft on Elastic Properties of Descending Thoracic Aorta Evaluated by Cardiac Magnetic Resonance Imaging
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : January 17, 2019
Actual Study Completion Date : January 17, 2019
Groups and Cohorts
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Intervention Details:
  • Procedure: Ascending aorta replacement with graft
    Patient with planned Ascending aorta replacement with graft
    Other Name: cardiac MRI

Outcome Measures
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Primary Outcome Measures :
  1. Aortic compliance of descending aorta (mm2/mmHg) [ Time Frame: post-operative cardiac MRI performing between 12 and 24 months ]

    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.



Secondary Outcome Measures :
  1. Aortic compliance of ascending aorta (mm2/mmHg) [ Time Frame: post-operative cardiac MRI performing between 12 and 24 months ]

    Aortic elastic properties of the ascending 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
19 patients operated in Cardiac Surgery unit of DIJON Hospital between September 2014 and December 2017.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior cardiac surgery
  • Contraindication to performing cardiac MRI
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MORGANT Marie-Catherine, PI, Centre Hospitalier La Chartreuse
ClinicalTrials.gov Identifier: NCT03817008    
Other Study ID Numbers: MORGANT 2019
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No