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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Agreement of Left Ventricular Ejection Fraction (LVEF) Measurements Between Echocardiography Techniques
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Agreement of Left Ventricular Ejection Fraction (LVEF) Measurements Between Echocardiography Techniques
时间窗: 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.
次要结局
- Agreement Between Echocardiography Techniques for Diagnosis of Cardiac Anomalies(Measured at the second visit (V2) at 2 weeks.)
- Dilated Cardiomyopathy Assessment(Measured at Visit 2 (V2), 2 weeks after baseline.)
- Quantitative Echocardiographic Measures(Measured at the second visit (V2) at 2 weeks.)
- Hypertrophic Cardiomyopathy Assessment(Measured at Visit 2 (V2), 2 weeks after baseline.)
- Valvulopathy Assessment(Measured at V2 (2 weeks))
- Systolic Pulmonary Arterial Pressure (PAP)(Measured at V2 (2 weeks))
- Left Ventricular Filling Pressure(Measured at V2 (2 weeks))
- Duration of Echocardiography(Measured at the second visit (V2) at 2 weeks.)
- Patient Satisfaction(Measured at the second visit (V2) at 2 weeks.)