Echocardiographic Analysis in Healthy Child.

Not Applicable

Completed

• Conditions: Healthy Child
• Interventions: Other: Echocardiography

• Registration Number: NCT02056925
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

· 2D Speckle Tracking echocardiography gained importance for the evaluation of ventricle contractility. Many indications have been developed in child population. However, the comparability of measurements between different software systems is not well defined. We choose to compare two software systems very often used in paediatric subjects : Echopac by General Electric and QLAB 9.0 by Philips. We offer a randomly second echocardiography to children which have normal heart. We compare Strain and Strain rate results between the two tests with a study of variability : ultrasound variability, operator variability, reader variability.

Detailed Description

· We select children addressed to paediatric cardiologist for not serious reason (heart murmur, chest pain, sport capacity...), which had normal heart after evaluation. If they satisfied all inclusive criteria (0 to 17 years old, parental agreement, social security fund) and neither exclusive criteria (cardiac, respiratory or muscular problems, chronic diseases, drug with heart impact, poor image quality), we randomly execute a second echocardiography. Echocardiography are done with Vivid 7 ultrasound (General Electrics) and/or IE 33 ultrasound (Philips) by one or two trained operators. Strain loops are taken on three standard apical views (two, three and four-chamber views), short axis midventricular and aortic views, sub-costal short axis aortic view and sub-costal four-chamber apical views. Strain analysis are done in a second steps by one or two trained readers with adapted software : Echopac (General Electrics) or QLAB 0.0 (Philips). Strain and Strain rate results are collected for each ventricle in each dimension.We compare results between the two tests and done statistical analysis with a study of variability : ultrasound variability, operator variability, reader variability (correlation coefficient). We also done a feasibility study with use of "poor image quality"exclusion criteria.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-06
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

• child (0 to 17 years included)
• normal heart
• parental agreement
• affiliate with social security fund

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Echocardiography	-

Primary Outcome Measures

Name	Time	Method
strain	during echocardiography	Strain and Strain rates measurements for each ventricle in longitudinal and radial dimension with a study of variability: ultrasound variability, operator variability, reader variability

Trial Locations

Locations (1)

Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital; 🇫🇷 Montpellier, France