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

NCT ID: NCT02551588

Last Updated: 2016-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-11-30

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

Conditions

Aortic Valve Stenosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Valvular aortic stenosis surgery

Intervention Type: PROCEDURE

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.

No interventions assigned to this group

Control subject

Patients without history of cardiac infarction, primary or secondary myocardiopathy or of radiotherapy or chemotherapy.

No interventions assigned to this group

Interventions

Valvular aortic stenosis surgery

Dilatation of Valvular aortic stenosis

Intervention Type: PROCEDURE

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

• 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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elie MOUSSEAUX, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Departement of Radiology, Hopital Europeen Georges Pompidou, Paris, France. Tel: +33 1 56 09 37 09. E-mail: elie.mousseaux@egp.aphp.fr

Locations

Departement of Radiology, Hopital Europeen Georges Pompidou,

Paris, , France

Countries

France

Other Identifiers

P081112

Identifier Type: -

Identifier Source: org_study_id