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Completed

NCT Number: NCT02551588

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Departement of Radiology, Hopital Europeen Georges Pompidou,

Paris, 75015, France

About this study

To validate new markers assessing cardiac fibrosis three groups of subjects were studied in controls subjects and patients with AVS in order to :

  • 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.
  • To validate these fibrosis markers estimated by MRI by histological analysis of biopsies performed in patients undergoing aortic valve replacement.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valvular aortic stenosis surgery

Procedure

Dilatation of Valvular aortic stenosis

Primary outcomes

  1. prevalence of myocardial fibrosis in MRI in patients with AVS

    Time frame: At one year

    Indices of myocardial fibrosis will been analysed as combined criteria to analyse myocardial fibrosis

Secondary outcomes

  1. comparison of these markers with myocardial histology

    Time frame: At inclusion and at one year

    Fibrosis estimated by MRI will be compared to fibrosis on myocardial biopsy symptomatic patients with surgery only)

  2. Correlation with Doppler Echocardiography Assessment, and wall stress estimate by using both cardiac MR and carotid artery pressure (applanation tonometry)

    Time frame: At inclusion and at one year

    Correlation of MRI with known markers of ventricular hypertrophy

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: RACINE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 16, 2015
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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