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Trial record 22 of 100 for:    "thoracic aortic aneurysms and aortic dissections" OR "Aortic Aneurysm, Thoracic"

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

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ClinicalTrials.gov Identifier: NCT02538822
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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 : September 1, 2014
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Correlation between index of risk of the rupture and in vivo physiological elasticity. [ Time Frame: 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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538822


Contacts
Contact: Ambroise DUPREY, MD (0)477828243 ambroise.duprey@chu-st-etienne.fr

Locations
France
CHU Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Ambroise Duprey, MD    (0)477828243    ambroise.duprey@chu-st-etienne.fr   
Principal Investigator: Ambroise Duprey, MD         
Sub-Investigator: Jean-Pierre Favre, PhD         
Sub-Investigator: Pierre Croisille, PhD         
Sub-Investigator: Jean-François Fuzellier, MD         
Sub-Investigator: Marco Volla, MD         
Sub-Investigator: Jean-Noël Albertini, MD         
Sub-Investigator: Salvatore Campisi, MD         
Sub-Investigator: Bertrand Chavent, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Ambroise DUPREY, MD CHU Saint-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02538822     History of Changes
Other Study ID Numbers: 1408061
ANSM ( Other Identifier: 2014-A00568-39 )
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
aortic aneurysm
thoracic ascending aorta
ATA
dynamic imaging
mechanical testing

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Rupture
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries