Echocardiographic Analysis in Healthy Child.

NCT ID: NCT02056925

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-09-30

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.

Conditions

Healthy Child

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental

Group Type: EXPERIMENTAL

Echocardiography

Intervention Type: OTHER

Interventions

Echocardiography

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal AMEDRO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Locations

Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

Montpellier, , France

Countries

France

References

Amedro P, Bredy C, Guillaumont S, De La Villeon G, Gamon L, Lavastre K, Meli AC, Richard S, Cazorla O, Lacampagne A, Mura T, Vincenti M. Speckle tracking echocardiography in healthy children: comparison between the QLAB by Philips and the EchoPAC by General Electric. Int J Cardiovasc Imaging. 2019 May;35(5):799-809. doi: 10.1007/s10554-018-01516-2. Epub 2019 Jan 8.

Reference Type: RESULT

PMID: 30623351 (View on PubMed)

Other Identifiers

9167

Identifier Type: -

Identifier Source: org_study_id