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

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Procedure: Valvular aortic stenosis surgery

• Registration Number: NCT02551588
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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
• Patients who have received prior clinical examination
• Patient receiving a french national social security
• After having obtain written informed consent.

Criteria for non-inclusion

• History of known or detectable infarction on EKG
• Known primary or secondary cardiomyopathy or detectable on echocardiography
• Thoracic radiotherapy or chemotherapy history
• Subject with usual contra-indications of MRI: claustrophobia, metallic objects.
• Patients with significant renal insufficiency with a clearance <90 ml / min estimated by the Cockcroft & Gault formula.
• Subject who could be planned for 2 CMR within two weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Valvular aortic stenosis surgery	Valvular aortic stenosis surgery	Patients with symptomatic AVS had indication for surgery. They were proposed to have per procedure cardiac biopsy. They were followed when possible one year after surgery.

Primary Outcome Measures

Name	Time	Method
prevalence of myocardial fibrosis in MRI in patients with AVS	At one year	Indices of myocardial fibrosis will been analysed as combined criteria to analyse myocardial fibrosis

Secondary Outcome Measures

Name	Time	Method
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	Correlation of MRI with known markers of ventricular hypertrophy
comparison of these markers with myocardial histology	At inclusion and at one year	Fibrosis estimated by MRI will be compared to fibrosis on myocardial biopsy symptomatic patients with surgery only)

Trial Locations

Locations (1)

Departement of Radiology, Hopital Europeen Georges Pompidou,; 🇫🇷 Paris, France