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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03474159
Other study ID # 2016-08
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 7, 2018
Est. completion date December 31, 2024

Study information

Verified date September 2023
Source French Cardiology Society
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Device:
Magnetic Resonance Imaging
Aortic distensibility measured in MRI at the Valsalva sinus and at the ascending tubular aortic level
Transthoracic echocardiography
Aortic distensibility measured in TTE of the same segments in TM and in B mode
Echography UltraFast
Carotid pulse rate measured on carotid arteries by UF

Locations

Country Name City State
France Hôpital Européen Georges Pompidou Paris

Sponsors (3)

Lead Sponsor Collaborator
French Cardiology Society Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Comparison of aortic stiffness evaluation with different methods TTE, MRI, UF 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).
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