Comparison Between a Robotic Tele-echo-cardiography Technique and a Standard Echocardiography in the Management of Heart Failure in the Guadeloupe Archipelago Between the University Hospital of Guadeloupe and the Marie-Galante Hospital

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de la Guadeloupe

About this trial

The TERdeblue-S study is a feasibility study of robotic remote echocardiography, not only in terms of technology but also in terms of its integration into a telemedicine system to improve access to the heart failure management system in the Guadeloupe archipelago. The main objective of this study is to study the agreement of the measurement of the left ventricular ejection fraction (FejVG) between in situ echocardiography (EIS) and two-dimensional remote echocardiography (TER) (distance and volumes).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Free, informed and written consent signed by the participant and the investigator

Person affiliated or benefiting from a social security scheme.

Systematic cardiovascular check-up or asymptomatic patient with cardiovascular risk factor (hypertension, diabetes, obesity, tobacco, alcohol)

Disqualifiers

Patient requiring urgent cardiological management with transfer to the University Hospital

Acute unstable heart failure, admission to CH Marie-Galante less than 5 days (less than one week)

Pregnant women

Trial design

Design model

Crossover

Treatments tested in this trial

  • in situ echocardiography (EIS)

    Diagnostic test

    In situ echocardiography (EIS) will be performed by the cardiologist present in Marie-Galante Hospital.

  • two-dimensional remote echocardiography (TER)

    Diagnostic test

    Remote echocardiography is performed by a cardiologist from a private practice in Guadeloupe, with a research nurse present at the patient's side at Marie-Galante Hospital.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Arm A: in situ ultrasound (EIS) performed firstExperimental treatment 2 interventions
Group B: Arm B: two-dimensional remote echocardiography (TER) performed firstExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Agreement of Left Ventricular Ejection Fraction (LVEF) Measurements Between Echocardiography Techniques

The main outcome measure is the agreement of left ventricular ejection fraction (LVEF) measurements between two echocardiography techniques. Agreement will be quantified using the intraclass correlation coefficient (ICC) and supplemented by Bland-Altman plots to visualize differences between methods.

Time frame
Measured at the second visit (V2) at 2 weeks.

Secondary outcomes

1

Agreement Between Echocardiography Techniques for Diagnosis of Cardiac Anomalies

Agreement between two echocardiography techniques for diagnosing cardiac anomalies (dilated cardiomyopathy, hypertrophic cardiomyopathy, and valvulopathies) will be evaluated using the Kappa coefficient. Sensitivity and specificity of each technique for each anomaly will also be reported.

Time frame
Measured at the second visit (V2) at 2 weeks.
2

Dilated Cardiomyopathy Assessment

Presence or absence of dilated cardiomyopathy will be defined according to left ventricular telediastolic diameter and reported as number of participants with dilated cardiomyopathy for each technique.

Time frame
Measured at Visit 2 (V2), 2 weeks after baseline.
3

Quantitative Echocardiographic Measures

Agreement between the two echocardiography techniques will be assessed using the intraclass correlation coefficient (ICC), paired Student's t-test, and Bland-Altman plots for the following measures: Diastolic function - mitral Doppler inflow/outflow (I/O) ratio and tissue Doppler I/O ratio; Aortic flow - measured from subaortic velocity-time integral (ITV); Systolic pulmonary arterial pressure - derived from tricuspid insufficiency using the Bernoulli formula; Right ventricular systolic function - assessed by TAPSE.

Time frame
Measured at the second visit (V2) at 2 weeks.
4

Hypertrophic Cardiomyopathy Assessment

Presence or absence of hypertrophic cardiomyopathy will be defined based on septal and posterior wall thickness and reported as number of participants with hypertrophic cardiomyopathy for each technique.

Time frame
Measured at Visit 2 (V2), 2 weeks after baseline.

Other outcomes

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