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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Ji Hyun Lee, MD
- 电话号码:82-31-787-7045
- 邮箱:jihyunlee310@snubh.org
学习地点
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Gyeonggido
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Seongnam-si、Gyeonggido、韩国、13620
- Seoul National University Bundang Hospital
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接触:
- Ji Hyun Lee, MD
- 电话号码:82-31-787-7045
- 邮箱:jihyunlee310@snubh.org
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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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无干预: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of major adverse cardiovascular events (MACE) within 30 days after surgery
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rate of preoperative cardiac imaging and functional testing
大体时间: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
大体时间: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
大体时间: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
大体时间:Within 30 days after surgery
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Within 30 days after surgery
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Time required for preoperative evaluation
大体时间:From randomization to surgery, up to 24 weeks
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From randomization to surgery, up to 24 weeks
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合作者和调查者
调查人员
- 首席研究员:Ji Hyun Lee, MD、Seul National University Bundang Hospital
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- B-2603-1033-001
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IPD 计划说明
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