Evaluation of Elastic Properties of Ascending Aorta

February 14, 2022 updated by: MORGANT Marie-Catherine, Centre Hospitalier La Chartreuse

Elastic Properties of the Ascending Aorta Evaluated by Imaging and Biaxial Testing

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

The preoperative cardiac MRI are planned in standard of care.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • claustrophobia
  • contraindication to performing cardiac MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aortic compliance of ascending aorta (mm2/mmHg)
Time Frame: preoperative cardiac MRI performing between 1 month and 1 day before surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum elastic modulus (MPa) of ascending aorta
Time Frame: biaxial testing performing between 1 and 6 hours after procedure
maximum elastic modulus is a local measurement of elastic properties which is obtained by biaxial testing
biaxial testing performing between 1 and 6 hours after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier La Chartreuse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

February 14, 2022

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (ACTUAL)

February 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • MECATHOR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Compliance, Magnetic Resonance Imaging, Biaxial Testing, Elastic Modulus

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