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Echocardiographic Analysis in Healthy Child.

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ClinicalTrials.gov Identifier: NCT02056925
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Child Other: Echocardiography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Speckle Tracking 2D Echocardiography in Healthy Child. Comparison of Two Different Software Systems : Echopac (General Electric) and QLAB 9.0 (Philips).
Study Start Date : December 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Experimental Other: Echocardiography



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056925


Locations
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France
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Pascal AMEDRO, MD, PhD UH Montpellier
Publications of Results:
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02056925    
Other Study ID Numbers: 9167
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019