NCT02056925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

December 17, 2013

Last Update Submit

January 14, 2019

Conditions

Healthy Child

Outcome Measures

Primary Outcomes (1)

  • strain

    Strain and Strain rates measurements for each ventricle in longitudinal and radial dimension with a study of variability: ultrasound variability, operator variability, reader variability

    during echocardiography

Study Arms (1)

Experimental

EXPERIMENTAL
Other: Echocardiography

Interventions

EchocardiographyOTHER
Experimental

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 30623351RESULT

Study Officials

  • Pascal AMEDRO, MD, PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2013

First Posted

February 6, 2014

Study Start

December 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

FR(1)