Clinical Trial: Valvular Aortic Stenosis: Study of Myocardiac Fibrosis by Magnetic Resonance Imagery

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Calcified Aortic Valve Stenosis (AVS). Markers of Fibrosis Using Cardiac Magnetic Resonance

Brief Summary: Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography Doppler, which assesses two key markers that are aortic valve pressure gradient and the aortic valve area. however these marker are a poor reflect of the clinical severity of AVS. The aim of the study is to validate new markers assessing cardiac fibrosis that might best or complementary markers.

Detailed Summary:

To validate new markers assessing cardiac fibrosis three groups of subjects were studied in controls subjects and patients with AVS in order to :

  1. Analyze myocardial fibrosis markers in MRI, the degree of hypertrophy, remodeling and wall shear stress in a control population and in three groups of subjects to RA progressively increasing risk: asymptomatic subjects without symptomatic subjects LV dysfunction, symptomatic patients with LV dysfunction. The factors favoring the appearance of fibrosis observed in MRI will be analyzed on all subjects.
  2. To validate these fibrosis markers estimated by MRI by histological analysis of biopsies performed in patients undergoing aortic valve replacement.
  3. Monitoring compliance with the distribution of markers of fibrosis and wall stress estimated on Initial MRI are factors of aggravation or not improved function and / or remodeling remote myocardial. Public hospitals in Paris

Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: prevalence of myocardial fibrosis in MRI in patients with AVS [ Time Frame: At one year ]

Indices of myocardial fibrosis will been analysed as combined criteria to analyse myocardial fibrosis


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • comparison of these markers with myocardial histology [ Time Frame: At inclusion and at one year ]
    Fibrosis estimated by MRI will be compared to fibrosis on myocardial biopsy symptomatic patients with surgery only)
  • Correlation with Doppler Echocardiography Assessment, and wall stress estimate by using both cardiac MR and carotid artery pressure (applanation tonometry) [ Time Frame: At inclusion and at one year ]
    Correlation of MRI with known markers of ventricular hypertrophy


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 4, 2015
Date Started: December 2012
Date Completion:
Last Updated: January 22, 2016
Last Verified: January 2016