AI-ECG for Preoperative Cardiovascular Risk Stratification Before General Surgery
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ji Hyun Lee, MD
- 電話番号：82-31-787-7045
- メール：jihyunlee310@snubh.org
研究場所
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Gyeonggido
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Seongnam-si、Gyeonggido、韓国、13620
- Seoul National University Bundang Hospital
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コンタクト：
- Ji Hyun Lee, MD
- 電話番号：82-31-787-7045
- メール：jihyunlee310@snubh.org
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of major adverse cardiovascular events (MACE) within 30 days after surgery
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rate of preoperative cardiac imaging and functional testing
時間枠：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
時間枠：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
時間枠：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
時間枠：Within 30 days after surgery
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Within 30 days after surgery
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Time required for preoperative evaluation
時間枠：From randomization to surgery, up to 24 weeks
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From randomization to surgery, up to 24 weeks
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協力者と研究者
捜査官
- 主任研究者：Ji Hyun Lee, MD、Seul National University Bundang Hospital
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- B-2603-1033-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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