Study C3S : Comparison Among Healthy Subject (RBHPCLERFOND)

• ClinicalTrials.gov Identifier: NCT03614624
• Recruitment Status: Unknown
• First Posted: August 3, 2018
• Last Update Posted: February 4, 2019
• Sponsor: University Hospital, Clermont-Ferrand
• Information provided by (Responsible Party): University Hospital, Clermont-Ferrand

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Device: Comparative standard echocardiography between two devices : Vivid 9 General Electric and Epiq 7 Philips	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 66 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All the healthy volunteers who consent to participate in the study, and who are eligible according to the protocol will have an clinical examination, an electrocardiogram and an echocardiography with two devices.
• Masking: None (Open Label)
• Masking Description: No masking description
• Primary Purpose: Prevention
• Official Title: Left Ventricular 2D and 3D Strain in Healthy Subject : Comparative Study Between Two Echocardiograph (Vivid 9 General Electric et Epiq 7 Philips)
• Actual Study Start Date: July 6, 2017
• Actual Primary Completion Date: July 31, 2018
• Estimated Study Completion Date: July 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Value of the longitudinal strain value, in left Ventricular in 2 and 3 dimension. [ Time Frame: 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.
2. Values of the radial strain value, in left Ventricular in 2 and 3 dimension. [ Time Frame: 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.
3. Values of the circumferential strain value, in left Ventricular in 2 and 3 dimension. [ Time Frame: 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.
4. Values of the global strain value, in left Ventricular in 2 and 3 [ Time Frame: 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.
5. Values of the segmental strain value, in left Ventricular in 2 and 3 [ Time Frame: 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.

Secondary Outcome Measures :

1. Values of longitudinal global strain of the right ventricle between two echographs (General Electric and Philips). [ Time Frame: 1 year ]
   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.
2. Values of segmental 2D of the right ventricle between two echographs (General Electric and Philips). [ Time Frame: 1 year ]
   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.
3. Values of strain 2D of the left atrium between two echographs (General Electric and Philips). [ Time Frame: 1 year ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Lise LACLAUTRE; 04 73 75 49 63; drci@chu-clermontferrand.fr

Locations

France

CHU de Clermont-Ferrand; Recruiting

Clermont-Ferrand, Auvergne, France, 63003

Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Principal Investigator: Guillaume CLERFOND

Sub-Investigator: Romain ESCHALIER, PU-PH

Sub-Investigator: Etienne GEOFFROY, PH

Sub-Investigator: Pascal MOTREFF, PU-PH

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

• Principal Investigator: Guillaume CLERFOND; University Hospital, Clermont-Ferrand

More Information

• Responsible Party: University Hospital, Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT03614624
• Other Study ID Numbers: CHU-402; 2016-A01584-47 ( Other Identifier: 2016-A01584-47 )
• First Posted: August 3, 2018
• Last Update Posted: February 4, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:

Healthy subject; Echocardiography; 2D and 3D Strain; General Electric; Philips