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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,380
- 试验地点
- 1
- 主要终点
- The incidence of newly diagnosed pulmonary hypertension or pulmonary hypertension-related cardiopulmonary diseases
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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 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.
排除标准
- •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).
结局指标
主要结局
The incidence of newly diagnosed pulmonary hypertension or pulmonary hypertension-related cardiopulmonary diseases
时间窗: Before surgery, or within 90 days after electrocardiography in patients who did not undergo surgery.
The incidence of newly diagnosed pulmonary hypertension (defined as an echocardiographic right ventricular systolic pressure \> 50 mmHg) or pulmonary hypertension-related cardiopulmonary diseases before surgery, or within 90 days after electrocardiography in patients who did not undergo surgery.
次要结局
- Incidence of Surgical Complications(From the date of surgery up to 3 months post-operation.)
- Length of Hospital Stay(From admission until hospital discharge (assessed up to 3 months).)
- Cardiovascular Mortality(From the date of surgery up to 3 months post-operation.)
- All-Cause Mortality(From the date of surgery up to 3 months post-operation.)