Perioperative Cardiovascular Risk, Postoperative Complications (Cardiopulmonary), Preoperative Care
Conditions
Keywords
Artificial intelligence, Electrocardiography, Perioperative cardiovascular risk, Preoperative evaluation, Major adverse cardiovascular events
Brief summary
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.
Interventions
DIAGNOSTIC_TESTAI-ECG-based preoperative risk stratification (ECG Buddy)
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.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Open-label treatment assignment with blinded endpoint adjudication (PROBE design). Outcomes are adjudicated by an independent committee blinded to treatment allocation.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 20 years or older * Patients scheduled for elective (non-emergent) general surgery * Willing and able to provide voluntary written informed consent
Exclusion criteria
* Emergency surgery * Surgery under local anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse cardiovascular events (MACE) within 30 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of preoperative cardiac imaging and functional testing | From randomization to surgery, up to 24 weeks | Proportion of patients undergoing preoperative echocardiography, coronary CT, SPECT, or stress testing. |
| 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 | — |
Countries
South Korea
Contacts
CONTACTJi Hyun Lee, MD
PRINCIPAL_INVESTIGATORJi Hyun Lee, MD
Seul National University Bundang Hospital
Outcome results
None listed