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

Study Overview
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Brief Summary
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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).

Detailed Description
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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

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

Conditions
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Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy

Intervention / Treatment
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* Device: Echography
* Device: Elastography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1 healthy volunteers<br>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<br>* 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<br>Device: Elastography<br>* cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and<br>|
| Other: Group 2 Patients CMH primitive<br>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<br>* 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<br>Device: Elastography<br>* cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and<br>|
| Other: Group 3 Patients primitive CMD:<br>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<br>* 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<br>Device: Elastography<br>* cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial diastolic stiffness UltrafastEcho (kPa) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child