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

NCT02538822 | Terminated

• 2 other identifiers: 1408061ANSM
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Aneurysm, Thoracic

Keywords

aortic aneurysm; thoracic ascending aorta; ATA; dynamic imaging; mechanical testing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

thoracic ascending aorta (ATA)

EXPERIMENTAL

the risk of rupture of thoracic ascending aorta (ATA) is assessed fom the dynamic imaging and mechanical testing

Device: dynamic imaging; Device: mechanical testing

Interventions

dynamic imaging DEVICE

In vivo study of biomechanical behavior of ATA from preoperative dynamic imaging : dynamic CT-scan and 4D-magnetic resonance imaging (MRI)

thoracic ascending aorta (ATA)

mechanical testing DEVICE

In vitro study of with mechanical inflation testing of ATA tissue harvested during surgery.

thoracic ascending aorta (ATA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contra-indication to MRI
• Chronic insufficiency kidney

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Aortic Aneurysm

Interventions

Mechanical Tests

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Materials Testing; Investigative Techniques

Study Officials

• Salvatore CAMPISI, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: October 6, 2014
• Primary Completion: September 16, 2018
• Study Completion: September 16, 2018
• Last Updated: May 24, 2023

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)