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

Not Applicable

Completed

• Conditions: Hypertrophic Cardiomyopathy; Dilated Cardiomyopathy
• Interventions: Device: Echography; Device: Elastography

• Registration Number: NCT02619825
• Lead Sponsor: French Cardiology Society

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-10-23
• Study Start: 2015-11
• Study First Submitted QC: 2015-11-30
• Study First Posted: 2015-12-02
• Primary Completion: 2017-05
• Study Completion: 2017-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 "healthy volunteers	Echography	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 \[0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years\]).
Group 2 Patients CMH primitive	Elastography	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.
Group 3 Patients primitive CMD:	Elastography	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.
Group 1 "healthy volunteers	Elastography	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 \[0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years\]).
Group 2 Patients CMH primitive	Echography	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.
Group 3 Patients primitive CMD:	Echography	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.

Primary Outcome Measures

Name	Time	Method
Myocardial diastolic stiffness UltrafastEcho (kPa)	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.

Trial Locations

Locations (1)

Chu Necker; 🇫🇷 Paris, France