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

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Procedure: Valvular aortic stenosis surgery

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Departement of Radiology, Hopital Europeen Georges Pompidou,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Valvular Aortic Stenosis with or without surgery (symptomatic patients) or controls

Description

PATIENTS :

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Valvular aortic stenosis surgery; Dilatation of Valvular aortic stenosis
Valvular aortic stenosis without surgery; These patients with asymptomatic AVS had no indication for surgery. They were followed when possible one year after inclusion.
Control subject; Patients without history of cardiac infarction, primary or secondary myocardiopathy or of radiotherapy or chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of myocardial fibrosis in MRI in patients with AVS	Indices of myocardial fibrosis will been analysed as combined criteria to analyse myocardial fibrosis	At one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Elie MOUSSEAUX, MD, PhD, Departement of Radiology, Hopital Europeen Georges Pompidou, Paris, France. Tel: +33 1 56 09 37 09. E-mail: elie.mousseaux@egp.aphp.fr

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Estimate): January 25, 2016
• Last Update Submitted That Met QC Criteria: January 22, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Fibrosis; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: P081112