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

Patient With Ascending Aortic Aneurysm With Surgical Indication for Replacement Clinical Trial

— MECATHOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03746964
• Other study ID #: MORGANT 2018 MECATHOR
• Status: Recruiting
• Start date: December 17, 2018
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Marie-Catherine MORGANT
• Phone: +33 3 80 29 33 52
• Email: mariecatherine.morgant[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Patient With Ascending Aortic Aneurysm With Surgical Indication for Replacement

Intervention

Procedure:
• Cardiac MRI
Preoperative cardiac MRI

Other:
• in-vitro elasticity tests
in-vitro elasticity tests performed on a segment of ascending aorta collected during surgery

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aortic compliance by cardiac MRI		Before surgery
Primary	In-vitro testing of the elasticity of the aortic wall fragment collected during surgery.		through study completion, an average of 12 months