Utilization of AI-ECG for Preoperative Cardiovascular Risk Stratification in General Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,200
- 试验地点
- 1
- 主要终点
- Incidence of major adverse cardiovascular events (MACE) within 30 days after surgery
研究概览
简要总结
This randomized controlled trial evaluates whether an artificial intelligence-enhanced electrocardiography (AI-ECG)-based strategy for preoperative cardiovascular risk stratification is noninferior to usual care in patients undergoing elective general surgery. Eligible patients are randomly assigned to either an AI-ECG-guided preoperative assessment strategy or usual preoperative care.
The primary outcome is the incidence of major adverse cardiovascular events (MACE) within 30 days after surgery, defined as a composite of all-cause death, ventricular fibrillation/tachycardia or cardiac arrest, non-fatal myocardial infarction, unplanned revascularization (PCI or CABG), mechanical ventilation for ≥3 days, and acute heart failure requiring intravenous diuretics.
Secondary outcomes include the rate of preoperative cardiac imaging and functional testing (echocardiography, coronary CT, SPECT, stress test), the rate of preoperative cardiology consultation, length of hospital stay, direct medical costs, and the time required for preoperative evaluation. The study aims to determine whether AI-ECG can safely guide preoperative cardiovascular evaluation while reducing unnecessary testing, resource use, and cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Open-label treatment assignment with blinded endpoint adjudication (PROBE design). Outcomes are adjudicated by an independent committee blinded to treatment allocation.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20 years or older
- •Patients scheduled for elective (non-emergent) general surgery
- •Willing and able to provide voluntary written informed consent
排除标准
- •Emergency surgery
- •Surgery under local anesthesia
结局指标
主要结局
Incidence of major adverse cardiovascular events (MACE) within 30 days after surgery
时间窗: Within 30 days after surgery
Composite of all-cause death, ventricular fibrillation/tachycardia or cardiac arrest, non-fatal myocardial infarction, unplanned revascularization (PCI or CABG), mechanical ventilation for ≥3 days, and acute heart failure requiring intravenous diuretics.
次要结局
- Rate of preoperative cardiac imaging and functional testing(From randomization to surgery, up to 24 weeks)
- Rate of preoperative cardiology consultation(From randomization to surgery, up to 24 weeks)
- Length of hospital stay(Through hospital discharge (up to 30 days))
- Direct medical costs(Within 30 days after surgery)
- Time required for preoperative evaluation(From randomization to surgery, up to 24 weeks)