AI-ECG for Preoperative Cardiovascular Risk Stratification Before General Surgery
17. august 2026 opdateret af: Seoul National University Bundang Hospital
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
3200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ji Hyun Lee, MD
- Telefonnummer: 82-31-787-7045
- E-mail: jihyunlee310@snubh.org
Studiesteder
-
-
Gyeonggido
-
Seongnam-si, Gyeonggido, Sydkorea, 13620
- Seoul National University Bundang Hospital
-
Kontakt:
- Ji Hyun Lee, MD
- Telefonnummer: 82-31-787-7045
- E-mail: jihyunlee310@snubh.org
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: AI-ECG-guided preoperative strategy
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.
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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.
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Ingen indgriben: Usual care
Patients receive usual preoperative care for cardiovascular evaluation according to standard institutional practice, without use of the AI-ECG-based strategy.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of major adverse cardiovascular events (MACE) within 30 days after surgery
Tidsramme: Within 30 days after surgery
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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.
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Within 30 days after surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of preoperative cardiac imaging and functional testing
Tidsramme: From randomization to surgery, up to 24 weeks
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Proportion of patients undergoing preoperative echocardiography, coronary CT, SPECT, or stress testing.
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From randomization to surgery, up to 24 weeks
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Rate of preoperative cardiology consultation
Tidsramme: From randomization to surgery, up to 24 weeks
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From randomization to surgery, up to 24 weeks
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Length of hospital stay
Tidsramme: Through hospital discharge (up to 30 days)
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Through hospital discharge (up to 30 days)
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Direct medical costs
Tidsramme: Within 30 days after surgery
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Within 30 days after surgery
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|
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Time required for preoperative evaluation
Tidsramme: From randomization to surgery, up to 24 weeks
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From randomization to surgery, up to 24 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Ji Hyun Lee, MD, Seul National University Bundang Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- Siontis 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.
- Thompson 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
31. maj 2029
Studieafslutning (Anslået)
31. maj 2029
Datoer for studieregistrering
Først indsendt
5. august 2026
Først indsendt, der opfyldte QC-kriterier
17. august 2026
Først opslået (Faktiske)
19. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B-2603-1033-001
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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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