GUARD-PH: Guided Use of AI-ECG for Risk Detection of PH in Surgery (GUARD-PH Trial)
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: Artificial Intelligence-Enabled Electrocardiography System.
- Кому может быть актуально
- Состояния в реестре: Pulmonary Hypertension (Diagnosis), Pre-operative Assessment, Postoperative Complications (Cardiopulmonary), Treatment Outcomes. 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
- Тайвань
- 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
A Prospective, Open-Label, Randomized Controlled Trial of an Artificial Intelligence Enabled Electrocardiography System for Preoperative Detection of Pulmonary Hypertension and Related Diseases(GUARD-PH)
Обзор
This study is a prospective, open-label, randomized controlled trial designed to evaluate a new artificial intelligence (AI) tool for heart monitoring. Researchers will use an AI-enabled electrocardiography (ECG) system to screen patients before they undergo surgery. The main goal is to determine if this AI system can accurately detect pulmonary hypertension and related heart diseases in the preoperative setting. The study is being conducted at Taipei Veterans General Hospital.
Подробное описание
This is an open-label, prospective, randomized controlled trial at Taipei Veterans General Hospital. Approximately 1,380 adult patients who already have a preoperative electrocardiogram (ECG) scheduled as part of routine care and have an established plan for elective surgery will be enrolled, along with approximately 30-60 participating physicians responsible for preoperative assessment and perioperative clinical care. The study evaluates whether integrating the Taiwan Medical Imaging Pulmonary Hypertension Detection System (TAIMedImg PHDS), an ECG-based clinical decision-support tool, during the preoperative preparation period can enable earlier identification of patients at risk of pulmonary hypertension and cardiopulmonary complications, and supports assessment of the potential cost-effectiveness of earlier risk recognition.
Patients are randomized to determine whether their responsible participating physician will receive TAIMedImg PHDS output derived from the patient's routine ECG. In the intervention arm, research staff upload the ECG to TAIMedImg PHDS and provide the analysis result to the participating physician; all other processes proceed as usual care. In the control arm, usual care proceeds without provision of TAIMedImg PHDS output. Randomization affects only access to this supplementary ECG-based output; it does not change patients' scheduled tests, clinical workflow, or rights to care. Clinical evaluation and management remain at the physician's discretion according to standard practice.
The study measures physicians' responses to ECG interpretation with versus without TAIMedImg PHDS output and documents the clinical decision-making trajectory, using routinely available medical record data for analysis. Results may inform improved preoperative pulmonary hypertension risk assessment and future perioperative care.
Вмешательства
- Диагностический тест Artificial Intelligence-Enabled Electrocardiography System
The intervention involves using an artificial intelligence-enabled electrocardiography system to analyze standard ECGs for the preoperative detection of pulmonary hypertension.
Первичные конечные точки
- The incidence of newly diagnosed pulmonary hypertension or pulmonary hypertension-related cardiopulmonary diseases [Срок оценки: Before surgery, or within 90 days after electrocardiography in patients who did not undergo surgery.]
Вторичные конечные точки (4)
- Incidence of Surgical Complications [Срок оценки: From the date of surgery up to 3 months post-operation.]
- Length of Hospital Stay [Срок оценки: From admission until hospital discharge (assessed up to 3 months).]
- Cardiovascular Mortality [Срок оценки: From the date of surgery up to 3 months post-operation.]
- All-Cause Mortality [Срок оценки: From the date of surgery up to 3 months post-operation.]
Критерии участия
Критерии включения
- Age between 18 and 80 years.
- Patients scheduled for non-cardiac surgery under general anesthesia.
- Patients who have a scheduled standard preoperative electrocardiogram (ECG).
- Patients capable of understanding the study and willing to provide medical records for research purposes, and who have signed the informed consent form.
Критерии исключения
- Patients scheduled for emergency surgery.
- Patients who explicitly refuse to participate or withdraw consent.
- Patients with specific comorbidities that interfere with ECG interpretation or data collection (e.g., implanted pacemakers).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Тайвань · 1 центр
- Taipei Veterans General Hospital — Taipei
Идентификаторы
NCT: NCT07344207 · 2025-10-004CCF