跳至主要内容
临床试验/NCT02056925
NCT02056925已完成不适用

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

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2013年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
163
试验地点
2
主要终点
strain

研究概览

简要总结

· 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.

详细描述

· 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

Experimental

Experimental

干预措施: Echocardiography (Other)

结局指标

主要结局

strain

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验