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

NCT02551588 | Completed DMC

• 1 other identifier: P081112
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

fibrosis; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• comparison of these markers with myocardial histology

  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)

  At inclusion and at one year

Study Arms (3)

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

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.

Interventions

Valvular aortic stenosis surgery PROCEDURE

Dilatation of Valvular aortic stenosis

Valvular aortic stenosis surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.
• History of known or detectable infarction on EKG
• Known primary or secondary cardiomyopathy or detectable on echocardiography
• Thoracic radiotherapy or chemotherapy history

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Departement of Radiology, Hopital Europeen Georges Pompidou,

Paris, 75015, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum

MeSH Terms

Conditions

Aortic Valve Stenosis; Fibrosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 16, 2015
• Study Start: December 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 25, 2016

Record last verified: 2016-01

Locations

FR (1)