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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Unknown status

CT.gov ID

NCT02538822

Collaborator

(none)

Enrollment

Location

Arm

70.9

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Thoracic	Device: dynamic imaging Device: mechanical testing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 6, 2014

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Correlation between index of risk of the rupture and in vivo physiological elasticity. [day 1]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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