Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging

Assessment of the Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging - A Monocentric Study

Aneurysms of the thoracic ascending aorta are a serious pathology which may threatens life by rupture or dissection. Their incidence is estimated at 10.4 per 100,000 people. At present, the only parameter for assessing the risk of complication is the maximum diameter of the aneurysm. The only way to avoid a complication is a surgical replacement of the aneurysmal aorta by a prosthetic tube. This procedure is performed by sternotomy and with extracorporeal circulation and its death rate ranges between 3% and 5%. Surgical repair is indicated when the diameter of the aneurysm exceeds 5.5 cm for degenerative atheromatous aneurysms or 5 cm in a patient with genetic disorder of connective tissue (Marfan disease or Ehlers-Danlos syndrome). However, there are aneurysms with diameter greater than the surgical threshold which remain stable. Conversely, complications have been described for aneurysms less than 4.5 cm in diameter. The criterion of diameter appears therefore as inadequate to assess the risk of complication of an aneurysm of the ascending aorta.Multiple methods have been described in the literature. One of them relies on in vitro mechanical testing on healthy or aneurysmal tissue. Another method is the vivo analysis from imaging (CT, MRI or ultrasound). So far, no algorithm is robust enough for predicting the risk of complication better than the universally used criterion of diameter.

The pathophysiology of these aneurysms has also been explored from histological studies. The investigators know that the microstructure of the aortic wall of an aneurysm is deteriorated with a degradation of elastin fibers and collagen that determine to a large extent its biomechanical behavior. Histological analysis appears inseparable from biomechanical analysis.

Study Overview

• Status: Terminated
• Conditions: Aortic Aneurysm, Thoracic
• Intervention / Treatment: Device: dynamic imaging; Device: mechanical testing

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ambroise Duprey, MD; Phone Number: (0)477828243; Email: ambroise.duprey@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France, 42055
    • CHU Saint-etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diameter of ATA exceeds 5.5 cm
• Diameter of ATA exceeds 5 cm in a patient with genetic disorder of connective tissue (Marfan disease or Ehlers-Danlos syndrome)
• Diameter of ATA exceeds 5 cm in a patient with aortic valvulopathy
• Written consent

Exclusion Criteria:

• Contra-indication to MRI
• Chronic insufficiency kidney

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: thoracic ascending aorta (ATA); the risk of rupture of thoracic ascending aorta (ATA) is assessed fom the dynamic imaging and mechanical testing	Device: dynamic imaging; In vivo study of biomechanical behavior of ATA from preoperative dynamic imaging : dynamic CT-scan and 4D-magnetic resonance imaging (MRI); Device: mechanical testing; In vitro study of with mechanical inflation testing of ATA tissue harvested during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between index of risk of the rupture and in vivo physiological elasticity.	The index of risk of rupture is a composite measure : an in vivo study of biomechanical behavior of aneurysmal aorta from preoperative dynamic imaging (dynamic CT-scan and 4D-MRI). It will determine the maximum stress borne by the aortic wall and its physiological elasticity.; an in vitro study with mechanical inflation testing of aneurysmal aortic tissue harvested during surgery. These tests will be conducted up to rupture and will bring results on the elasticity of the aortic wall of the aneurysm and its mode of failure.; finally, a histological analysis, with measurement of elastin and collagen content. The physiological elasticity is measured from MRI	day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Salvatore CAMPISI, MD, CHU Saint-etienne

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2014
• Primary Completion (Actual): September 16, 2018
• Study Completion (Actual): September 16, 2018

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: aortic aneurysm; thoracic ascending aorta; ATA; dynamic imaging; mechanical testing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Aortic Diseases; Rupture; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: 1408061; ANSM (Other Identifier: 2022-A02513-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No