Echocardiography, Doppler, Heart Failure, Remote Consultation, Teleconsultation
Conditions
Keywords
heart failure, remote echocardiography doppler, telemedicine
Brief summary
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).
Detailed description
Considered as the new global epidemic of the 21st century, heart failure (HF) is a major public health issue. In 2010, the Guadeloupe region already had the highest rate of heart failure deaths in all French departments, furthermore cardiac decompensation of chronic heart failure is the first cardiovascular pathology to be managed in emergency medicine and the first cardiovascular cause of hospitalization. Marie-Galante is an island in the Guadeloupe archipelago, 36% of whose hospital stays are covered by the University Hospital Currently, access to specialized care in Marie-Galante, particularly cardiological care, is very limited with one to two monthly consultations by a specialist cardiologist accessible to a population . Rather, remote echocardiography has been the subject of experimental studies but has not yet been proposed as part of an optimization of the management of a specific cardiovascular disease at separate sites. This is a prospective multicentre study (two cardiologists in private practice of Guadeloupe and one at the Marie-Galante Hospital) interventional cross-over study in which the left ventricular ejection fraction (LVEF) will be the main judgement criterion. Patients will be randomized to determine the order of implementation of the techniques (echocardiography and then teleecardiography or the reverse). In addition, in order to take into account the operator effect, each of the 2 cardiologists will move alternately either for remote echocardiography or to Marie-Galante for in situ echocardiography. The visit (V1) takes place at Marie-Galante's CH, as soon as possible after inclusion by the generalist practicionner or the cardiologist (V0) and is carried out by the state-registered nurse with a blood sample (biological check-up and biological collection) and ECG Holter place over 24 hours.
Interventions
DIAGNOSTIC_TESTin situ echocardiography (EIS)
In situ echocardiography (EIS) will be performed by the cardiologist present in Marie-Galante Hospital.
DIAGNOSTIC_TESTtwo-dimensional remote echocardiography (TER)
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.
Sponsors
GIRCI SOHO
Centre Hospitalier Universitaire de la Guadeloupe
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Intervention model description
This is a prospective multicentre study (one cardiologist in a private practice in Guadeloupe and one at the Marie-Galante Hospital) interventional cross-over study in which the measurements obtained successively by tele-echo-cardiography and standard echocardiography will be compared. Among the set of parameters to be measured, we have chosen the left ventricular ejection fraction (LVEF) as the main judgement criterion because this measure defines the type of heart failure.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Free, informed and written consent signed by the participant and the investigator * Person affiliated or benefiting from a social security scheme. * Patient meeting at least one of the following criteria: * Systematic cardiovascular check-up or asymptomatic patient with cardiovascular risk factor (hypertension, diabetes, obesity, tobacco, alcohol) * Clinical suspicion of heart disease and/or chronic heart failure with stability of at least one week. * Family history of heart disease and/or sudden death
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of Left Ventricular Ejection Fraction (LVEF) Measurements Between Echocardiography Techniques | Measured at the second visit (V2) at 2 weeks. | 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
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Echocardiography Techniques for Diagnosis of Cardiac Anomalies | Measured at the second visit (V2) at 2 weeks. | 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 | Measured at Visit 2 (V2), 2 weeks after baseline. | 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 | Measured at the second visit (V2) at 2 weeks. | 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 | Measured at Visit 2 (V2), 2 weeks after baseline. | 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. |
| Valvulopathy Assessment | Measured at V2 (2 weeks) | Presence or absence of aortic or mitral stenosis and regurgitation will be reported as number of participants with valvulopathies for each technique. |
| Systolic Pulmonary Arterial Pressure (PAP) | Measured at V2 (2 weeks) | Systolic PAP will be measured from tricuspid regurgitation or estimated indirectly from systolic pulmonary ejection flow. Reported in mmHg. |
| Left Ventricular Filling Pressure | Measured at V2 (2 weeks) | Changes in left ventricular (LV) filling pressures will be assessed using the E/e' ratio (mitral Doppler flow / tissue Doppler flow at the mitral annulus). |
| Duration of Echocardiography | Measured at the second visit (V2) at 2 weeks. | Total duration of each echocardiography session will be recorded in minutes for both techniques. |
| Patient Satisfaction | Measured at the second visit (V2) at 2 weeks. | Patient satisfaction with the tele-echocardiography procedure will be assessed using an adapted TeleHealth Satisfaction Questionnaire (TSQ). Each item is scored on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied), resulting in a total score range of 0 to 100 after standardization, where higher scores indicate greater satisfaction. All assessments will be conducted at the tele-echocardiography session by a blinded evaluator or self-reported by the patient. |
Countries
Guadeloupe
Contacts
Primary Contactmelanie petapermal, Master degree
Backup ContactValérie Hamony Soter
Outcome results
None listed