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

Primary Purpose

Aortic Aneurysm, Thoracic

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dynamic imaging
mechanical testing
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Aneurysm, Thoracic focused on measuring aortic aneurysm, thoracic ascending aorta, ATA, dynamic imaging, mechanical testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

  • Contra-indication to MRI
  • Chronic insufficiency kidney

Sites / Locations

  • CHU Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

thoracic ascending aorta (ATA)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 31, 2015
Last Updated
May 23, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02538822
Brief Title
Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging
Official Title
Assessment of the Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging - A Monocentric Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
low inclusion rates
Study Start Date
October 6, 2014 (Actual)
Primary Completion Date
September 16, 2018 (Actual)
Study Completion Date
September 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Thoracic
Keywords
aortic aneurysm, thoracic ascending aorta, ATA, dynamic imaging, mechanical testing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thoracic ascending aorta (ATA)
Arm Type
Experimental
Arm Description
the risk of rupture of thoracic ascending aorta (ATA) is assessed fom the dynamic imaging and mechanical testing
Intervention Type
Device
Intervention Name(s)
dynamic imaging
Intervention Description
In vivo study of biomechanical behavior of ATA from preoperative dynamic imaging : dynamic CT-scan and 4D-magnetic resonance imaging (MRI)
Intervention Type
Device
Intervention Name(s)
mechanical testing
Intervention Description
In vitro study of with mechanical inflation testing of ATA tissue harvested during surgery.
Primary Outcome Measure Information:
Title
Correlation between index of risk of the rupture and in vivo physiological elasticity.
Description
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
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore CAMPISI, MD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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