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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
in situ echocardiography (EIS)
Diagnostic testIn situ echocardiography (EIS) will be performed by the cardiologist present in Marie-Galante Hospital.
two-dimensional remote echocardiography (TER)
Diagnostic testRemote 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Centre Hospitalier Universitaire de la Guadeloupe
Lead sponsor
GIRCI SOHO
Collaborator