Study C3S : Comparison Among Healthy Subject

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-06

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

No masking description

Study Groups

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Comparison of two devices

Patients receive clinical examination, electrocardiogramm and echocardiography.

Group Type EXPERIMENTAL

Comparative standard echocardiography between two devices : Vivid 9 General Electric and Epiq 7 Philips

Intervention Type DEVICE

Comparison of the various values of strain with the echograph General Electric and the electrograph Philips.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes