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

Aortic Valve Stenosis Clinical Trial

— RACINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02551588
• Other study ID #: P081112
• Status: Completed
• Phase: N/A
• First received: September 4, 2015
• Last updated: January 22, 2016
• Start date: December 2012
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The French National Agency for Medicines and Health Products Safety (ANSM)
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• Valvular aortic stenosis surgery
Dilatation of Valvular aortic stenosis

Locations

Country	Name	City	State
France	Departement of Radiology, Hopital Europeen Georges Pompidou,	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No