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Clinical Trials/NCT02056925
NCT02056925
Completed
Not Applicable

Speckle Tracking 2D Echocardiography in Healthy Child. Comparison of Two Different Software Systems : Echopac (General Electric) and QLAB 9.0 (Philips).

University Hospital, Montpellier1 site in 1 country163 target enrollmentDecember 2013
ConditionsHealthy Child

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Child
Sponsor
University Hospital, Montpellier
Enrollment
163
Locations
1
Primary Endpoint
strain
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
September 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

strain

Time Frame: 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

Study Sites (1)

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