Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie)

October 31, 2017 updated by: French Cardiology Society

Non-Invasive Evaluation of Myocardial Stiffness by Elastography Pediatric Cardiology Under

First, investigators must determine the physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]).

Secondly, investigators will evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with cardiomyopathy and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values. The total population of the study will be 120 children (40 healthy, 80 patients).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Monocenter Prospective, open-label, non-randomized. All patients included in the study have a specific consultation built around a clinical examination and echocardiography, in two stages, with estimates of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measures of all echocardiographic parameters estimated in children with a clinical ultrasound machine (Philips and General Electric).

Following this consultation, clinic and electrocardiographic monitoring period will be observed for 30 minutes, to ensure the safety of our procedure.

Required subjects: 40 healthy volunteers + 80 = 120 persons

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75005
        • CHU Necker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Group 1. Healthy Age criteria met by group [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]

  • consultation for heart murmur
  • Recipient of a social protection scheme or entitled (excluding AME)
  • Signed informed consent by the holders of parental authority

Group 2. Patients MHC nonobstructive:

  • Age criteria met by group [1 month-1 year 1 year-5 years]
  • Diagnostic criteria of non-obstructive HCM validated by the medical team of pediatric cardiology center (Necker)
  • Recipient of a social protection scheme or entitled (excluding AME)
  • Signed informed consent by the holders of parental authority

Group 3. Patients primitive CMD:

  • Age criteria met by group [1 month-1 year 1 year-5 years]
  • Diagnostic criteria of primary CMD validated by the medical team of pediatric cardiology center (Necker)
  • Recipient of a social protection scheme or entitled (excluding AME)
  • Signed informed consent

Exclusion Criteria:

Group 1. Healthy Patients:

  • Age> 15 years
  • Heart and Systemic Pathology identified
  • metabolic and tissue pathology.
  • known genetic pathology may have cardiac involvement.
  • No echogenicity,
  • Allergy echocardiography gel.

Group 2. Group CMH primitive Patients

  • No echogenicity,,
  • Allergy echocardiography gel.
  • Arrhythmia.
  • Pacemaker or defibrillator

Group 3. Patients primitive CMD:

  • No echogenicity,,
  • Allergy echocardiography gel.
  • Arrhythmia.
  • Pacemaker or defibrillator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Group 1 "healthy volunteers
Echography and Elastography To determine physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]).
Device: Echography
cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measurement of all echocardiographic parameters estimated in children with a clinical ultrasound Machine
Device: Elastography
cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and
OTHER: Group 2 Patients CMH primitive
Echography and Elastography To evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with Hypertrophic Cardiomyopathy (HCM) non obstructive primitive and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values.
Device: Echography
cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measurement of all echocardiographic parameters estimated in children with a clinical ultrasound Machine
Device: Elastography
cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and
OTHER: Group 3 Patients primitive CMD:
Echography and Elastography To evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with Dilated Cardiomyopathy primitive and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values.
Device: Echography
cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measurement of all echocardiographic parameters estimated in children with a clinical ultrasound Machine
Device: Elastography
cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial diastolic stiffness UltrafastEcho (kPa)
Time Frame: through study completion, an average of 1 year
Normal values and intra-observer variability and inter-observer variability to demonstrate that the Aixplorer® myocardial elastography provides a reproducible assessment of myocardial stiffness.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Investigators

  • Study Chair: Olivier VILLEMAIN, MD, LAngevin Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2015

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

July 1, 2017

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (ESTIMATE)

December 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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