Prospective Evaluation of the Biomechanical Properties of the Thoracic Aorta Coupling Magnetic Resonance Imaging and In-vitro Elasticity Tests in Patients With Ascending Aortic Aneurysm (MECATHOR)

February 16, 2024 updated by: Centre Hospitalier Universitaire Dijon
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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
Time Frame
aortic compliance by cardiac MRI
Time Frame: Before surgery
Before surgery
In-vitro testing of the elasticity of the aortic wall fragment collected during surgery.
Time Frame: through study completion, an average of 12 months
through study completion, an average of 12 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

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 17, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 16, 2018

First Posted (Actual)

November 20, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MORGANT 2018 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.

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Locations

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