Perioperative Cardiovascular RiskNCT07774689
AI-ECG for Preoperative Cardiovascular Risk Stratification Before General Surgery
A study testing AI-ECG-based preoperative risk stratification (ECG Buddy) in people with Perioperative Cardiovascular Risk and Postoperative Complications (Cardiopulmonary), run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Perioperative Cardiovascular Risk, Postoperative Complications (Cardiopulmonary), Preoperative Care
- What is being tested?
- AI-ECG-based preoperative risk stratification (ECG Buddy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2026to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 years or older
- Patients scheduled for elective (non-emergent) general surgery
- Willing and able to provide voluntary written informed consent
Who cannot join
- Emergency surgery
- Surgery under local anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13620
Ji Hyun Lee, MD, 82-31-787-7045, jihyunlee310@snubh.org
About this study
Official title: Utilization of AI-ECG for Preoperative Cardiovascular Risk Stratification in General Surgery: A Randomized Controlled Trial
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.
- Conditions
- Perioperative Cardiovascular Risk, Postoperative Complications (Cardiopulmonary), Preoperative Care
- Being tested
- AI-ECG-based preoperative risk stratification (ECG Buddy)
- Keywords
- Artificial intelligence, Electrocardiography, Perioperative cardiovascular risk, Preoperative evaluation, Major adverse cardiovascular events
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-ECG-based preoperative risk stratification (ECG Buddy)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-ECG-guided preoperative strategy | Experimental | 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. Receives: Diagnostic Test: AI-ECG-based preoperative risk stratification (ECG Buddy) |
| Usual care | No intervention | Patients receive usual preoperative care for cardiovascular evaluation according to standard institutional practice, without use of the AI-ECG-based strategy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days after surgery
Secondary outcomes (5)
Rate of preoperative cardiac imaging and functional testing
Proportion of patients undergoing preoperative echocardiography, coronary CT, SPECT, or stress testing.
Measured: From randomization to surgery, up to 24 weeks
Rate of preoperative cardiology consultation
Measured: From randomization to surgery, up to 24 weeks
Length of hospital stay
Measured: Through hospital discharge (up to 30 days)
Direct medical costs
Measured: Within 30 days after surgery
Time required for preoperative evaluation
Measured: From randomization to surgery, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perioperative Cardiovascular RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji Hyun Lee, MD, Principal investigator, Seul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774689
- Sponsor's protocol ID
- B-2603-1033-001
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Cho Y, Yoon M, Kim J, Lee JH, Oh IY, Lee CJ, Kang SM, Choi DJ. Artificial Intelligence-Based Electrocardiographic Biomarker for Outcome Prediction in Patients With Acute Heart Failure: Prospective Cohort Study. J Med Internet Res. 2024 Jul 3;26:e52139. doi: 10.2196/52139.
PubMed 38959500Siontis KC, Noseworthy PA, Attia ZI, Friedman PA. Artificial intelligence-enhanced electrocardiography in cardiovascular disease management. Nat Rev Cardiol. 2021 Jul;18(7):465-478. doi: 10.1038/s41569-020-00503-2. Epub 2021 Feb 1.
PubMed 33526938Thompson A, Fleischmann KE, Smilowitz NR, de Las Fuentes L, Mukherjee D, Aggarwal NR, Ahmad FS, Allen RB, Altin SE, Auerbach A, Berger JS, Chow B, Dakik HA, Eisenstein EL, Gerhard-Herman M, Ghadimi K, Kachulis B, Leclerc J, Lee CS, Macaulay TE, Mates G, Merli GJ, Parwani P, Poole JE, Rich MW, Ruetzler K, Stain SC, Sweitzer B, Talbot AW, Vallabhajosyula S, Whittle J, Williams KA Sr; Peer Review Committee Members. 2024 AHA/ACC/ACS/ASNC/HRS/SCA/SCCT/SCMR/SVM Guideline for Perioperative Cardiovascular Management for Noncardiac Surgery: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Nov 5;150(19):e351-e442. doi: 10.1161/CIR.0000000000001285. Epub 2024 Sep 24.
PubMed 39316661
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of AI-ECG for Preoperative Cardiovascular Risk Stratification in General Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07774689
- Acronym / sponsor ID
- B-2603-1033-001
- Conditions
- Perioperative Cardiovascular Risk, Postoperative Complications (Cardiopulmonary), Preoperative Care
- Keywords
- Artificial intelligence, Electrocardiography, Perioperative cardiovascular risk, Preoperative evaluation, Major adverse cardiovascular events
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-ECG-guided preoperative strategy | Experimental | Diagnostic Test: AI-ECG-based preoperative risk stratification (ECG Buddy)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. |
| Usual care | No intervention | –Patients receive usual preoperative care for cardiovascular evaluation according to standard institutional practice, without use of the AI-ECG-based strategy. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 20 years or older
- Patients scheduled for elective (non-emergent) general surgery
- Willing and able to provide voluntary written informed consent
Key exclusion criteria (2 listed)
- Emergency surgery
- Surgery under local anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-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. | Diagnostic test | AI-ECG-guided preoperative strategy |
Primary outcome
Incidence of major adverse cardiovascular events (MACE) within 30 days after surgery
Time frame: 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.
5 secondary outcomes
Rate of preoperative cardiac imaging and functional 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 38959500Cho Y, Yoon M, Kim J, Lee JH, Oh IY, Lee CJ, Kang SM, Choi DJ. Artificial Intelligence-Based Electrocardiographic Biomarker for Outcome Prediction in Patients With Acute Heart Failure: Prospective Cohort Study. J Med Internet Res. 2024 Jul 3;26:e52139. doi: 10.2196/52139.
- Background: PubMed 33526938Siontis KC, Noseworthy PA, Attia ZI, Friedman PA. Artificial intelligence-enhanced electrocardiography in cardiovascular disease management. Nat Rev Cardiol. 2021 Jul;18(7):465-478. doi: 10.1038/s41569-020-00503-2. Epub 2021 Feb 1.
- Background: PubMed 39316661Thompson A, Fleischmann KE, Smilowitz NR, de Las Fuentes L, Mukherjee D, Aggarwal NR, Ahmad FS, Allen RB, Altin SE, Auerbach A, Berger JS, Chow B, Dakik HA, Eisenstein EL, Gerhard-Herman M, Ghadimi K, Kachulis B, Leclerc J, Lee CS, Macaulay TE, Mates G, Merli GJ, Parwani P, Poole JE, Rich MW, Ruetzler K, Stain SC, Sweitzer B, Talbot AW, Vallabhajosyula S, Whittle J, Williams KA Sr; Peer Review Committee Members. 2024 AHA/ACC/ACS/ASNC/HRS/SCA/SCCT/SCMR/SVM Guideline for Perioperative Cardiovascular Management for Noncardiac Surgery: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Nov 5;150(19):e351-e442. doi: 10.1161/CIR.0000000000001285. Epub 2024 Sep 24.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ji Hyun Lee, MD principal investigator
Seul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-ECG-based preoperative risk stratification (ECG Buddy) in people with Perioperative Cardiovascular Risk and Postoperative Complications (Cardiopulmonary), run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji Hyun Lee, MD (82-31-787-7045, jihyunlee310@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiovascular events (MACE) within 30 days after surgery (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07774689, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.