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NCT Number: NCT07515859

Risk Stratification of Cancer Therapy-Related Cardiac Dysfunction Using AI-Enhanced Electrocardiography

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

No intervention (retrospective observational study)

Other

This is a retrospective observational study using existing clinical data. No intervention or diagnostic procedure is applied to participants.

Primary outcomes

  1. Incidence of cancer therapy-related cardiac dysfunction (CTRCD)

    Time frame: 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.

Secondary outcomes

  1. All-cause mortality

    Time frame: From initiation of first chemotherapy up to 24 months.

    Death from any cause during the follow-up period.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Korea Health Industry Development Institute
  • VUNO Inc.

Registry information

Important dates

Study start
2006
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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