An interventional study of AI-ECG-based preoperative risk stratification (ECG Buddy) in Perioperative Cardiovascular Risk, Postoperative Complications (Cardiopulmonary) and Preoperative Care, sponsored by Seoul National University Bundang Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Health services research
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 3,200 is above the median of 114 across 766 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo preoperative cardiovascular risk stratification guided by the output of the AI-ECG device (ECG Buddy). Further preoperative cardiovascular evaluation and cardiology consultation are directed according to the AI-ECG-based assessment.
Diagnostic Test: AI-ECG-based preoperative risk stratification (ECG Buddy)
Patients receive usual preoperative care for cardiovascular evaluation according to standard institutional practice, without use of the AI-ECG-based strategy.
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.
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
Plan to share: Undecided — Individual participant data will not be shared. De-identified data may be made available upon reasonable request to the principal investigator, subject to institutional and ethics committee approval.
Start is estimated for Sep 2026; primary completion for May 2029, 32 months later.
Of 391 non-industry interventional studies with no phase under Postoperative Complications, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's planned 32 months is above that.
Counting every sponsor, half of 395 studies reached it within 21 months; a quarter within 8 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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