Study C3S : Comparison Among Healthy Subject (RBHPCLERFOND)

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Comparative standard echocardiography between two devices : Vivid 9 General Electric and Epiq 7 Philips

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • Recruiting
      • CHU de Clermont-Ferrand
      • Principal Investigator: Guillaume CLERFOND
      • Sub-Investigator: Romain ESCHALIER, PU-PH
      • Sub-Investigator: Etienne GEOFFROY, PH
      • Sub-Investigator: Pascal MOTREFF, PU-PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comparison of two devices; Patients receive clinical examination, electrocardiogramm and echocardiography.	Device: Comparative standard echocardiography between two devices : Vivid 9 General Electric and Epiq 7 Philips; Comparison of the various values of strain with the echograph General Electric and the electrograph Philips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of the longitudinal strain value, in left Ventricular in 2 and 3 dimension.	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.	1 year
Values of the radial strain value, in left Ventricular in 2 and 3 dimension.	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.	1 year
Values of the circumferential strain value, in left Ventricular in 2 and 3 dimension.	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.	1 year
Values of the global strain value, in left Ventricular in 2 and 3	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.	1 year
Values of the segmental strain value, in left Ventricular in 2 and 3	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Values of longitudinal global strain of the right ventricle between two echographs (General Electric and Philips).	The acquisition of the ultrasound loops on both echographs are 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.	1 year
Values of segmental 2D of the right ventricle between two echographs (General Electric and Philips).	The acquisition of the ultrasound loops on both echographs are 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.	1 year
Values of strain 2D of the left atrium between two echographs (General Electric and Philips).	The acquisition of the ultrasound loops on both echographs are 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.	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Anticipated): July 31, 2019

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Echocardiography; Healthy subject; 2D and 3D Strain; General Electric; Philips
• Other Study ID Numbers: CHU-402; 2016-A01584-47 (Other Identifier: 2016-A01584-47)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No