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CompletedNCT02551588RACINEUpdated Jan 25, 2016

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

An observational study in Aortic Valve Stenosis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-01-25.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
70
Ages
18 Years to 90 Years
Sex
All
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Study 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.

Read the 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
02

Conditions studied

  • Aortic Valve Stenosis

Keywords

  • fibrosis
  • Magnetic resonance imaging
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In context

Aortic Valve Stenosis

1,007 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.

This study's enrollment of 70 is below the median of 200 across 431 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,578 studies on the registry; 1,030 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
70 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • ProcedureValvular aortic stenosis surgery

    Dilatation of Valvular aortic stenosis

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What researchers measure

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

    Time frame: At one year

Secondary outcomes

  1. comparison of these markers with myocardial histology

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

    Time frame: At inclusion and at one year

  2. 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

    Time frame: At inclusion and at one year

07

Study locations

1 site
  • Departement of Radiology, Hopital Europeen Georges Pompidou,
    Paris, 75015, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2012, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2015
First posted
Sep 16, 2015
Start
Dec 2012
Primary completionActual
Nov 2015
CompletionActual
Nov 2015
Last update
Jan 25, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02551588
Responsible party
Sponsor
First posted
Sep 16, 2015
Start date
Dec 2012
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Jan 25, 2016

Study contacts

Elie MOUSSEAUX, MD, PhD
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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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