Evaluation of Aortic Stiffness as a Prognostic Indicator of Aortic Dilatation in Patients With Bicuspid Aortic Valve by Multimodal Imaging

NCT03474159 | Completed

• 1 other identifier: 2016-08
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bicuspid Aortic Valve

Keywords

Bicuspid aortic valve; aortic aneurysm; stiffness; Pulse wave velocity

Outcome Measures

Primary Outcomes (1)

• Evaluation of the progression of artic dilation with MRI

  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.

  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).

Secondary Outcomes (1)

• Comparison of aortic stiffness evaluation with different methods TTE, MRI, UF

  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).

Study Arms (1)

patients

OTHER

patients with Bicuspid aortic valve (defined using the Sievers classification) and confirmed with either Transthoracic Echocardiography, computed tomography, or Magnetic Resonance Imaging Carotid pulse rate measured on carotid arteries by UF

Device: Magnetic Resonance Imaging; Device: Transthoracic echocardiography; Device: Echography UltraFast

Interventions

Magnetic Resonance Imaging DEVICE

Aortic distensibility measured in MRI at the Valsalva sinus and at the ascending tubular aortic level

Also known as: MRI

patients

Transthoracic echocardiography DEVICE

Aortic distensibility measured in TTE of the same segments in TM and in B mode

Also known as: TTE

patients

Echography UltraFast DEVICE

Carotid pulse rate measured on carotid arteries by UF

Also known as: UF

patients

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• French Cardiology Society: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease; Aortic Aneurysm

Interventions

Magnetic Resonance Imaging; Echocardiography

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aneurysm; Vascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Cardiac Imaging Techniques; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Emmanuel MESSAS

  APHP

  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: February 23, 2018
• First Posted: March 22, 2018
• Study Start: November 7, 2018
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)