Clinical trial NCT03614624: Study C3S : Comparison Among Healthy Subject
Official title: Left Ventricular 2D and 3D Strain in Healthy Subject : Comparative Study Between Two Echocardiograph (Vivid 9 General Electric et Epiq 7 Philips)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Keywords: Healthy subject
Echocardiography
2D and 3D Strain
General Electric
Philips
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Value of the longitudinal strain value, in left Ventricular in 2 and 3 dimension.
timeFrame: 1 year
measure: Values of the radial strain value, in left Ventricular in 2 and 3 dimension.
timeFrame: 1 year
measure: Values of the circumferential strain value, in left Ventricular in 2 and 3 dimension.
timeFrame: 1 year
measure: Values of the global strain value, in left Ventricular in 2 and 3
timeFrame: 1 year
measure: Values of the segmental strain value, in left Ventricular in 2 and 3
timeFrame: 1 year
Secondary outcomes:
measure: Values of longitudinal global strain of the right ventricle between two echographs (General Electric and Philips).
timeFrame: 1 year
measure: Values of segmental 2D of the right ventricle between two echographs (General Electric and Philips).
timeFrame: 1 year
measure: Values of strain 2D of the left atrium between two echographs (General Electric and Philips).
timeFrame: 1 year
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Guillaume CLERFOND
role: PRINCIPAL_INVESTIGATOR
References: