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

NCT07515859 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31486

Last updated 2026-04-13

No results posted yet for this study

Summary

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.

Conditions

  • Cancer Therapy-Related Cardiac Dysfunction
  • Heart Failure
  • Left Ventricular Dysfunction

Interventions

OTHER

No intervention (retrospective observational study)

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

Sponsors & Collaborators

  • Korea Health Industry Development Institute

    collaborator OTHER_GOV

  • VUNO Inc.

    collaborator INDUSTRY

  • Yonsei University

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07515859 on ClinicalTrials.gov