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Идёт набор NCT07265986

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

Без фазы С лечением Heart Failure Remote Consultation, Teleconsultation Echocardiography, Doppler

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: in situ echocardiography (EIS), two-dimensional remote echocardiography (TER).
Кому может быть актуально
Состояния в реестре: Heart Failure, Remote Consultation, Teleconsultation, Echocardiography, Doppler. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Guadeloupe
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Agreement of Left Ventricular Ejection Fraction (LVEF) Measurements Between Echocardiography Techniques [Срок оценки: Measured at the second visit (V2) at 2 weeks.]
Вторичные конечные точки (9)
  • Agreement Between Echocardiography Techniques for Diagnosis of Cardiac Anomalies [Срок оценки: Measured at the second visit (V2) at 2 weeks.]
  • Dilated Cardiomyopathy Assessment [Срок оценки: Measured at Visit 2 (V2), 2 weeks after baseline.]
  • Quantitative Echocardiographic Measures [Срок оценки: Measured at the second visit (V2) at 2 weeks.]
  • Hypertrophic Cardiomyopathy Assessment [Срок оценки: Measured at Visit 2 (V2), 2 weeks after baseline.]
  • Valvulopathy Assessment [Срок оценки: Measured at V2 (2 weeks)]
  • Systolic Pulmonary Arterial Pressure (PAP) [Срок оценки: Measured at V2 (2 weeks)]
  • Left Ventricular Filling Pressure [Срок оценки: Measured at V2 (2 weeks)]
  • Duration of Echocardiography [Срок оценки: Measured at the second visit (V2) at 2 weeks.]
  • Patient Satisfaction [Срок оценки: Measured at the second visit (V2) at 2 weeks.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Диагностика

Центры проведения

Guadeloupe · 3 центра
  • Centre Hospitalier Sainte-Marie de Marie-Galante — Grand-Bourg
  • Centre de Cardiologie Zac Colin — Petit-Bourg
  • Cabinet de cardiologie TONCOEURTONKA — Petit-Canal

Идентификаторы

NCT: NCT07265986 · PAP_RI2_2019/02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗