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

N/ACompletedNCT02619825

French Cardiology Society120 enrolled

Overview

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).

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

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

120

Conditions

Dilated Cardiomyopathy

Interventions

EchographyDEVICE

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

ElastographyDEVICE

cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and

Eligibility

Sex: ALLMin age: 1 DayMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: through study completion, an average of 1 year