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Study C3S : Comparison Among Healthy Subject (RBHPCLERFOND)

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Healthy Volunteers

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03614624
2016-A01584-47 (Other Identifier)
CHU-402

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

66 participants in 1 patient group

Comparison of two devices
Experimental group
Description:
Patients receive clinical examination, electrocardiogramm and echocardiography.
Treatment:
Device: Comparative standard echocardiography between two devices : Vivid 9 General Electric and Epiq 7 Philips

Trial contacts and locations

1

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Central trial contact

Lise LACLAUTRE

Data sourced from clinicaltrials.gov

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