Skip to main content
Clinical Trials/NCT02551588
NCT02551588
Completed
N/A

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country70 target enrollmentDecember 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aortic Valve Stenosis
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
70
Locations
1
Primary Endpoint
prevalence of myocardial fibrosis in MRI in patients with AVS
Status
Completed
Last Updated
10 years ago

Overview

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 Description

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

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
November 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Echocardiography considered as normal and / or age-related
  • Patients who have received prior clinical examination
  • Patient receiving a social security scheme or entitled, or CMU
  • After having giving written informed consent.
  • Patients symptomatic with indication of surgery (group surgery) or not

Exclusion Criteria

  • With one of the following cardiac abnormalities: atrial fibrillation, more than moderate either aortic or mitral valve regurgitation
  • Heart valve surgery history (aortic, mitral, tricuspid and pulmonary).
  • Indication for cardiac surgery other than on the aortic valve.
  • Usual counter-indications of MRI: Pace-maker, defibrillator, metallic objects including gadolinium allergy.
  • Patients with severe renal insufficiency with a clearance \<30 ml / min estimated by the Cockcroft \& Gault formula.
  • Patient who cannot be followed over the duration of a year.
  • CONTROLS (healthy volunteers)
  • Inclusion criteria:
  • Normal EKG
  • Echocardiography considered normal and / or age-related

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Correlation with Doppler Echocardiography Assessment, and wall stress estimate by using both cardiac MR and carotid artery pressure (applanation tonometry)(At inclusion and at one year)
  • comparison of these markers with myocardial histology(At inclusion and at one year)

Study Sites (1)

Loading locations...

Similar Trials