NCT03614624

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 20, 2018

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

July 20, 2018

Last Update Submit

February 1, 2019

Conditions

Healthy Volunteers

Keywords

Healthy subjectEchocardiography2D and 3D StrainGeneral ElectricPhilips

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • Values of longitudinal global strain of the right ventricle between two echographs (General Electric and Philips).

    1 year

  • Values of segmental 2D of the right ventricle between two echographs (General Electric and Philips).

    1 year

  • Values of strain 2D of the left atrium between two echographs (General Electric and Philips).

    1 year

Study Arms (1)

Comparison of two devices

EXPERIMENTAL

Patients receive clinical examination, electrocardiogramm and echocardiography.

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

Interventions

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

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

Comparison of two devices

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

Study Officials

  • Guillaume CLERFOND

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

04 73 75 49 63drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking description
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2018

First Posted

August 3, 2018

Study Start

July 6, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2019

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

FR(1)