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

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Brief Title

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

Official Title

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

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 Type

Observational

Primary Outcome

prevalence of myocardial fibrosis in MRI in patients with AVS

Secondary Outcome

 comparison of these markers with myocardial histology

Condition

Aortic Valve Stenosis

Intervention

Valvular aortic stenosis surgery

Study Arms / Comparison Groups

 Valvular aortic stenosis surgery
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

70

Start Date

December 2012

Completion Date

November 2015

Primary Completion Date

November 2015

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Elie MOUSSEAUX, MD, PhD, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT02551588

Organization ID

P081112

Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Study Sponsor

Elie MOUSSEAUX, MD, PhD, Principal Investigator, Departement of Radiology, Hopital Europeen Georges Pompidou, Paris, France. Tel: +33 1 56 09 37 09. E-mail: [email protected]

Verification Date

January 2016