CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31,486 enrolled
Drug / intervention
No intervention (retrospective observational study)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07515859
NCT07515859N/ACompleted

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

Yonsei University·observational·Posted Apr 7, 2026·Updated Apr 13, 2026

In Brief

An observational study evaluating No intervention (retrospective observational study) for Cancer Therapy-Related Cardiac Dysfunction and 2 related conditions. Completed, enrolled 31,486 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 7, 2026
Enrollment StartMay 1, 2006
Primary CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 16.7 yearsPosted 3 months ago

Interventions

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.