Wearable Devices Faciliate the Management of AMI Patients
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Acute Myocardial Infarction. Базовые параметры: 18 лет — 75 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Wearable Device for Characterizing AMI Patients After Primary PCI and Predicting the Clinical Outcomes
Обзор
The study will explore the use of wearable technology to consistently monitor patients with acute myocardial infarction (AMI) receiving primary percutaneous coronary intervention (PCI). Parameters such as heart rate, sleep time, physical activity, and blood pressure will be collected and analyzed to characterize the patients and predict clinical outcomes.
Подробное описание
The aim of this study is to explore in-hospital patient management and predict clinical outcomes in AMI patients receiving primary PCI through wearable technology (e.g., smart watches and wristband devices). The investigators expect to involve patients diagnosed with AMI, including ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI), who are admitted to the cardiac Cardiac Intensive Care Unit (CICU) after primary PCI.
With written consent, eligible participants will be consistently monitored by a wearable device during the CICU stay, in addition to a conventional monitoring system. Vital signs including heart rate (beats/minute), oxygen saturation (%) blood pressure (mmHg), and other crucial parameters such as sleep patterns will be recorded. The collected data will be analyzed using AI-assisted and machine learning techniques, integrated with other clinical data to construct models that support risk stratification, guide clinical decision-making, improve the quality of nursing care, and predict long-term prognosis for these patients. Serial follow-ups (6-month, annual, and long-term) will be performed, and important information such as cardiac function assessed by echocardiography, the incidence of major adverse cardiovascular events, and life qualities will be collected for each follow-up.
Первичные конечные точки
- Heart Rate Pattern assessed artificial intelligence (AI)-assisted analysis [Срок оценки: Throughout the full course of hospitalization, with an average of 1 week.]
Вторичные конечные точки (5)
- Cardiac function assessed by echocardiography [Срок оценки: At 1-month, 6-month and 1-year follow-ups.]
- The event rate of coronary revascularization [Срок оценки: From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.]
- The event rate of heart failure [Срок оценки: From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.]
- The event rate of re-infarction [Срок оценки: From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.]
- Cardiovascular mortality (%) [Срок оценки: From date of enrollment until date of death from cardiovascular causes, or assessed up to 12 months.]
Критерии участия
Критерии включения
- Aged 18-75 years old
- Diagnosed with STEMI or NSTEMI (ACC/AHA guidelines)
- Half male and half female
- Undergo CAG and PCI treatment;
- Written informed consent.
Критерии исключения
- People under the age of 18 years old;
- Patients who are pregnant/breastfeeding;
- Patients who are allergic to the metallic or plastic components of the wearable devices
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Renji Hospital — Шанхай
Идентификаторы
NCT: NCT06995495 · EARLY-MYO Wearable Devices