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

French Cardiology Society

Status: Completed

Conditions: Hypertrophic Cardiomyopathy; Dilated Cardiomyopathy

Treatments: Device: Elastography; Device: Echography

Study type: Interventional

Funder types: Other

Identifiers

NCT02619825

2014-03

Details and patient eligibility

About

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).

Full 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

Enrollment: 120 patients

Sex: All

Ages: 1 day to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 3 patient groups

Group 1 "healthy volunteers

Other group

Description:

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 \[0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years\]).

Treatment:

Device: Elastography

Device: Echography

Group 2 Patients CMH primitive

Other group

Description:

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.

Treatment:

Device: Elastography

Device: Echography

Group 3 Patients primitive CMD:

Other group

Description:

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.

Treatment:

Device: Elastography

Device: Echography