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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
3,200
A standard 12-lead ECG is analyzed by an AI-enhanced ECG algorithm (ECG Buddy) to stratify preoperative cardiovascular risk. Designated AI-ECG biomarkers are used as decision thresholds to guide subsequent preoperative cardiovascular evaluation and cardiology consultation.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
Incidence of major adverse cardiovascular events (MACE) 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.
Time frame: Within 30 days after surgery
Rate of preoperative cardiac imaging and functional testing
Proportion of patients undergoing preoperative echocardiography, coronary CT, SPECT, or stress testing.
Time frame: From randomization to surgery, up to 24 weeks
Rate of preoperative cardiology consultation
Time frame: From randomization to surgery, up to 24 weeks
Length of hospital stay
Time frame: Through hospital discharge (up to 30 days)
Direct medical costs
Time frame: Within 30 days after surgery
Time required for preoperative evaluation
Time frame: From randomization to surgery, up to 24 weeks
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