跳至主要内容
临床试验/NCT03614624
NCT03614624Unknown不适用

Left Ventricular 2D and 3D Strain in Healthy Subject : Comparative Study Between Two Echocardiograph (Vivid 9 General Electric et Epiq 7 Philips)

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年7月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
66
试验地点
2
主要终点
Value of the longitudinal strain value, in left Ventricular in 2 and 3 dimension.

研究概览

简要总结

The aim of the C3S study is research an equivalence with longitudinal, radial and circumferential, global and segmental strain value, in left Ventricular in 2 and 3 dimension between two echograph General Electric Vivid 9 (GE Vingmed, Horton, Norway) et Philips Epiq 7.

详细描述

Healthy volunteer will be inform about the study by email and press. They could join the clinical research team by email and phone to ask more questions about the study. Then the investigator, verify the eligibiliy of the volunteers and schedule an appointment for the visit of inclusion. During this visit, the patient's consent will be collected. One echocardiography will be complete on echograph General Electric Vivid 9 to collect the clinical data necessary for the study and to eliminate the presence of criteria of exclusions, the acquisition of the loops of ultrasound will be realized on both echographs by a first investigator. A second investigator will make the post-treatment of the ultrasound images on consoles ECHOPAC PC version 201, General Electric Medical System and Q Station version 3.5, Philips Healthcare in two different times, to obtain the values of the various strain.

Furthermore, an clinical exam, an ECG, a questionnary will be realized.

研究设计

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

盲法说明

No masking description

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years' old
  • Without any cardiac pathology
  • Not taking long-term treatments, except oral contraception
  • Consented to participate in the study

排除标准

  • Existence of heart disease : myocardial revascularization, primitive cardiopathy (dilated or hypertrophic cardiopathy), moderate or severe valvulopathy, pulmonary hypertension, congenital heart disease operated or not, previous cardiac heart failure, previous rhythm disturbance and/or pacemaker, hypertension treated or untreated, peripheral artery disease : occlusive arteriopathy of the lower limbs, peripheral arterial aneurysm, stenosis or peripheral arterial occlusion.
  • Practicing intensive sport (more than 6 hours per week)
  • Untreated type 2 or 1 diabetes , treated dyslipidemia, chronic alcoholic intoxication (men more than 3 units of alcohol per day and women more than 2 units per day)
  • Existence of heart disease or previous heart disease
  • Pregnant or lactating women,
  • Dependent adult
  • Patients minor,
  • Decline the study,
  • Existence of a psychiatric pathology
  • Inability to grant its informed consent
  • No affiliation to a social security scheme

结局指标

主要结局

Value of the longitudinal strain value, in left Ventricular in 2 and 3 dimension.

时间窗: 1 year

The acquisition of the ultrasound loops on both echographs is realized at the same time. The various values of strain are obtained after post-treatment of the ultrasound loops on ECHOPAC PC version 201 software for the echograph General Electric and the Q Station version 3.5 software for the echograph Phillips. The post-treatment on both software are made in two different times to avoid possible biases.

Values of the radial strain value, in left Ventricular in 2 and 3 dimension.

时间窗: 1 year

The acquisition of the ultrasound loops on both echographs is realized at the same time. The various values of strain are obtained after post-treatment of the ultrasound loops on ECHOPAC PC version 201 software for the echograph General Electric and the Q Station version 3.5 software for the echograph Phillips. The post-treatment on both software are made in two different times to avoid possible biases.

Values of the circumferential strain value, in left Ventricular in 2 and 3 dimension.

时间窗: 1 year

The acquisition of the ultrasound loops on both echographs is realized at the same time. The various values of strain are obtained after post-treatment of the ultrasound loops on ECHOPAC PC version 201 software for the echograph General Electric and the Q Station version 3.5 software for the echograph Phillips. The post-treatment on both software are made in two different times to avoid possible biases.

Values of the global strain value, in left Ventricular in 2 and 3

时间窗: 1 year

The acquisition of the ultrasound loops on both echographs is realized at the same time. The various values of strain are obtained after post-treatment of the ultrasound loops on ECHOPAC PC version 201 software for the echograph General Electric and the Q Station version 3.5 software for the echograph Phillips. The post-treatment on both software are made in two different times to avoid possible biases.

Values of the segmental strain value, in left Ventricular in 2 and 3

时间窗: 1 year

The acquisition of the ultrasound loops on both echographs is realized at the same time. The various values of strain are obtained after post-treatment of the ultrasound loops on ECHOPAC PC version 201 software for the echograph General Electric and the Q Station version 3.5 software for the echograph Phillips. The post-treatment on both software are made in two different times to avoid possible biases.

次要结局

  • Values of segmental 2D of the right ventricle between two echographs (General Electric and Philips).(1 year)
  • Values of strain 2D of the left atrium between two echographs (General Electric and Philips).(1 year)
  • Values of longitudinal global strain of the right ventricle between two echographs (General Electric and Philips).(1 year)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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