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Evaluation of Aortic Stiffness as a Prognostic Indicator of Aortic Dilatation in Patients With Bicuspid Aortic Valve (BAV) by Multimodal Imaging (MRI, Echocardiography and Ultrafast Ultrasound Imaging) (IRM BAO)

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ClinicalTrials.gov Identifier: NCT03474159
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : February 21, 2019
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France U979
Centre National de la Recherche Scientifique, France
Information provided by (Responsible Party):
French Cardiology Society

Brief Summary:

The objective is the development and validation of morphological markers informative of aortic dilatation in order to improve the precision of the risk of aneurysm of the thoracic aorta and of acute aortic syndrome for patients with bicuspid aortic valve (BAV).

The primary objective of this study is to demonstrate a correlation between the aortic local pulse wave velocity (PWV) measured with MRI and the progression of the thoracic aorta diameters measured by MRI after a follow-up of 2 years.


Condition or disease Intervention/treatment Phase
Bicuspid Aortic Valve Device: Magnetic Resonance Imaging Device: Transthoracic echocardiography Device: Echography UltraFast Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Aortic Stiffness as a Prognostic Indicator of Aortic Dilatation in Patients With Bicuspid Aortic Valve (BAV) by Multimodal Imaging (MRI, Echocardiography and Ultrafast Ultrasound Imaging)
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
patients
patients with Bicuspid aortic valve (defined using the Sievers classification) and confirmed with either Transthoracic Ecocardiogrphy, computed tomography, or Magnetic Resonance Imaging Carotid pulse rate measured on carotid arteries by UF
Device: Magnetic Resonance Imaging
Aortic distensibility measured in MRI at the Valsalva sinus and at the ascending tubular aortic level
Other Name: MRI

Device: Transthoracic echocardiography
Aortic distensibility measured in TTE of the same segments in TM and in B mode
Other Name: TTE

Device: Echography UltraFast
Carotid pulse rate measured on carotid arteries by UF
Other Name: UF




Primary Outcome Measures :
  1. Evaluation of the progression of artic dilation with MRI [ Time Frame: For each patient, inclusion in the study will be associated with one-day hospitalization with: MRI (=first MRI), TTE and UF (at T0). Patients will then be re-examined after 2 years to perform a second MRI to assess aortic dilatation (T=2 years). ]
    The measure evaluates a change, which is why there is more than one time point. For patients, a first MRI and a second MRI will be performed after 2 years (+/- 2 months) in order to evaluate prospectively the progression of aortic dilatation according to stiffness parameters.


Secondary Outcome Measures :
  1. Comparison of aortic stiffness evaluation with different methods TTE, MRI, UF [ Time Frame: For each patient, inclusion in the study will be associated with one-day hospitalization with: MRI (=first MRI), TTE and UF (at T0). Patients will then be re-examined after 2 years to perform a second MRI to assess aortic dilatation (T=2 years). ]
    Comparison of aortic stiffness evaluation with different methods TTE, MRI, UF



Information from the National Library of Medicine

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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:

  • Adults over 18 years of age,
  • confirmed BAV by TTE computed tomography or MRI.
  • Adults benefiting from a social security scheme,
  • having received information on the research
  • having signed the consent form

Exclusion Criteria:

  • Patient with a syndromic form of BAV:
  • Loeys-Dietz syndrome,
  • Turner syndrome
  • Williams-Beuren syndrome
  • Shone syndrome

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): NCT03474159


Contacts
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Contact: Tessa BERGOT +33 1 44 90 70 33 tessa.bergot@sfcardio.fr

Locations
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France
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Emmanuel Messas         
Principal Investigator: Emmanuel MESSAS         
Sponsors and Collaborators
French Cardiology Society
Institut National de la Santé Et de la Recherche Médicale, France U979
Centre National de la Recherche Scientifique, France
Investigators
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Principal Investigator: Emmanuel MESSAS APHP
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Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT03474159    
Other Study ID Numbers: 2016-08
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by French Cardiology Society:
Bicuspid aortic valve
aortic aneurysm
stiffness
Pulse wave velocity
Additional relevant MeSH terms:
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Heart Valve Diseases
Cardiovascular Diseases
Heart Diseases