NCT02619825

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: French Cardiology Society · Academic / Other
• Sex: All
• Age: 1 Day – 15 Years
• Healthy volunteers: Accepted

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

Conditions

• Dilated Cardiomyopathy
• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-05-01
• Completion: 2017-07-01
• First posted: 2015-12-02
• Last updated: 2017-11-06

Locations

1 site across 1 country: France