Risk Stratification of Cancer Therapy-Related Cardiac Dysfunction Using AI-Enhanced Electrocardiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31,486
- 试验地点
- 1
- 主要终点
- Incidence of cancer therapy-related cardiac dysfunction (CTRCD)
研究概览
简要总结
This study investigates the use of AI-enhanced electrocardiogram (ECG) for risk stratification of cancer therapy-related cardiac dysfunction (CTRCD) before the initiation of cancer therapy. The study includes patients treated with anthracyclines, HER2 inhibitors, or immune checkpoint inhibitors (ICIs) at Severance Hospital between May 2006 and November 2022, who underwent an ECG within 90 days prior to chemotherapy. The primary goal is to evaluate whether AI-ECG can accurately predict the risk of CTRCD and compare its performance to existing risk stratification models. In addition, we aim to assess whether the variation in AI-ECG scores between pre- and post-chemotherapy assessments could serve as a predictor of CTRCD. Eligible participants are adults without prior heart failure, cardiomyopathy, or myocarditis, and with baseline left ventricular ejection fraction (LVEF) ≥40%. For trajectory analysis, only patients with an additional ECG within 90 days after chemotherapy are included. The primary outcome is the development of CTRCD within 12 months after the last treatment cycle (and no more than 24 months after the first). The secondary outcomes are severe CTRCD (LVEF <40%) and all-cause mortality.
This study aims to validate the clinical utility of AI-enhanced ECG as a simple, accessible, and cost-effective tool for predicting CTRCD across diverse cancer treatment regimens, including newer immunotherapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients prescribed anthracycline (doxorubicin, daunorubicin, epirubicin, aclarubicin, idarubicin), HER2 inhibitor (trastuzumab, emtansine, tucatinib, trastuzumab deruxtecan, pertuzumab), or immune checkpoint inhibitors (ipilimumab, nivolumab, atezolizumab, pembrolizumab, durvalumab, avelumab)
- •ECG performed within 90 days prior to the first chemotherapy treatment
- •Age ≥ 19 years
- •For trajectory analysis: patients with an additional ECG within 90 days after the first chemotherapy
排除标准
- •Age < 19 years
- •History of heart failure, cardiomyopathy, or myocarditis (confirmed by ICD codes)
- •Prior exposure to anthracycline, HER2 inhibitor, or immune checkpoint inhibitor therapy
- •Baseline left ventricular ejection fraction (LVEF) < 40% on echocardiography within 1 year prior to chemotherapy
研究组 & 干预措施
Low baseline AI-ECG risk for CTRCD
Patients classified as low risk for CTRCD based on baseline AI-ECG LVSD prediction probability before initiation of cancer therapy.
干预措施: No intervention (retrospective observational study) (Other)
High baseline AI-ECG risk for CTRCD
Patients classified as high risk for CTRCD based on baseline AI-ECG LVSD prediction probability before initiation of cancer therapy.
干预措施: No intervention (retrospective observational study) (Other)
结局指标
主要结局
Incidence of cancer therapy-related cardiac dysfunction (CTRCD)
时间窗: From initiation of first chemotherapy up to 24 months.
CTRCD defined as ≥10%p drop in left ventricular ejection fraction (LVEF) from baseline to 40% to 49.9% OR \<10%p drop to 40-49.9% with a reduction in GLS by \>15% OR new LVEF reduction to \<40% from baseline LVEF, OR hospitalization for heart failure or diagnosis of cardiomyopathy defined by ICD codes,, diagnosed within 12 months after the last treatment cycle and no more than 24 months after the first cycle cardiotoxic cancer therapy. LVEF is assessed by either echocardiography or MUGA (Multi-gated acquisition nuclear imaging) scan.
次要结局
- All-cause mortality(From initiation of first chemotherapy up to 24 months.)