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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: in situ echocardiography (EIS), two-dimensional remote echocardiography (TER).
- Who it may be relevant to
- Registry conditions: Heart Failure, Remote Consultation, Teleconsultation, Echocardiography, Doppler. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Guadeloupe
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test in situ echocardiography (EIS)
In situ echocardiography (EIS) will be performed by the cardiologist present in Marie-Galante Hospital. - Diagnostic test two-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.
Primary outcome measures
- Agreement of Left Ventricular Ejection Fraction (LVEF) Measurements Between Echocardiography Techniques [Time frame: Measured at the second visit (V2) at 2 weeks.]
Secondary outcome measures (9)
- Agreement Between Echocardiography Techniques for Diagnosis of Cardiac Anomalies [Time frame: Measured at the second visit (V2) at 2 weeks.]
- Dilated Cardiomyopathy Assessment [Time frame: Measured at Visit 2 (V2), 2 weeks after baseline.]
- Quantitative Echocardiographic Measures [Time frame: Measured at the second visit (V2) at 2 weeks.]
- Hypertrophic Cardiomyopathy Assessment [Time frame: Measured at Visit 2 (V2), 2 weeks after baseline.]
- Valvulopathy Assessment [Time frame: Measured at V2 (2 weeks)]
- Systolic Pulmonary Arterial Pressure (PAP) [Time frame: Measured at V2 (2 weeks)]
- Left Ventricular Filling Pressure [Time frame: Measured at V2 (2 weeks)]
- Duration of Echocardiography [Time frame: Measured at the second visit (V2) at 2 weeks.]
- Patient Satisfaction [Time frame: Measured at the second visit (V2) at 2 weeks.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Guadeloupe · 3 centers
- Centre Hospitalier Sainte-Marie de Marie-Galante — Grand-Bourg
- Centre de Cardiologie Zac Colin — Petit-Bourg
- Cabinet de cardiologie TONCOEURTONKA — Petit-Canal
Identifiers
NCT: NCT07265986 · PAP_RI2_2019/02