Cancer Therapy-Related Cardiac DysfunctionNCT07515859
Risk Stratification of Cancer Therapy-Related Cardiac Dysfunction Using AI-Enhanced Electrocardiography
An observational study of Cancer Therapy-Related Cardiac Dysfunction and Heart Failure, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cancer Therapy-Related Cardiac Dysfunction, Heart Failure, Left Ventricular Dysfunction
- How many people
- 31,486 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2006to 31 Dec 2022
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were prescribed anthracycline, HER2 inhibitor, or ICI agents and have ECG prescription within 90 days before their first chemotherapy treatment at Severance hospital from May 2006 to November 2022.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul, 03722
About this study
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.
- Being tested
- No intervention (retrospective observational study)
- Keywords
- Cardiotoxicity, Electrocardiography, Chemotherapy, AI-ECG, CTRCD, Risk Stratification, Cardio-Oncology
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention (retrospective observational study) | |
| 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. Receives: Other: No intervention (retrospective observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cancer therapy-related cardiac dysfunction (CTRCD)
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.
Measured: From initiation of first chemotherapy up to 24 months.
Secondary outcomes (1)
All-cause mortality
Death from any cause during the follow-up period.
Measured: From initiation of first chemotherapy up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 May 2006
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cancer Therapy-Related Cardiac DysfunctionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31,486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute, VUNO Inc.
- Responsible party
- Principal investigator, Iksung Cho, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515859
- Sponsor's protocol ID
- 4-2025-0326
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and privacy regulations related to the use of retrospective clinical data.
Publications
Stein-Merlob AF, Rothberg MV, Ribas A, Yang EH. Cardiotoxicities of novel cancer immunotherapies. Heart. 2021 Nov;107(21):1694-1703. doi: 10.1136/heartjnl-2020-318083. Epub 2021 Mar 15.
PubMed 33722826Lee SH, Cho I, You SC, Cha MJ, Chang JS, Kim WD, Go KY, Kim DY, Seo J, Shim CY, Hong GR, Kang SM, Ha JW, Rha SY, Kim HS. Cancer Therapy-Related Cardiac Dysfunction in Patients Treated with a Combination of an Immune Checkpoint Inhibitor and Doxorubicin. Cancers (Basel). 2022 May 7;14(9):2320. doi: 10.3390/cancers14092320.
PubMed 35565449Scalia IG, Farina JM, Pietri MP, Sarkis P, Javadi N, Bismee NN, Viggiano T, Tagle-Cornell C, Koepke L, Kenyon C, Novais B, Tiseer Abbas M, Tamarappoo BK, Lester SJ, Banerjee I, Ibrahim R, Larsen C, Lee KS, Arsanjani R, Ayoub C. Artificial Intelligence for Identification of Patients with Increased Risk of Severe Cancer Therapy-Related Cardiac Dysfunction Following Anthracycline Therapy. Am J Med. 2025 Nov;138(11):1561-1568.e1. doi: 10.1016/j.amjmed.2025.06.035. Epub 2025 Jun 25.
PubMed 40578470Choi HM, Kim J, Park J, Park JB, Kim HK, Choi HJ, Yoon YE, Cho GY, Cho Y, Hwang IC. AI derived ECG global longitudinal strain compared to echocardiographic measurements. Sci Rep. 2024 Nov 2;14(1):26458. doi: 10.1038/s41598-024-78268-8.
PubMed 39488646Mihos CG, Liu JE, Anderson KM, Pernetz MA, O'Driscoll JM, Aurigemma GP, Ujueta F, Wessly P; American Heart Association Council on Peripheral Vascular Disease; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology. Speckle-Tracking Strain Echocardiography for the Assessment of Left Ventricular Structure and Function: A Scientific Statement From the American Heart Association. Circulation. 2025 Sep 9;152(10):e96-e109. doi: 10.1161/CIR.0000000000001354. Epub 2025 Aug 6.
PubMed 40765507Gomes C, Geels J, Debray TPA, Malekzadeh A, Asselbergs FW, Linschoten M. Risk prediction models for cancer therapy related cardiac dysfunction in patients with cancer and cancer survivors: systematic review and meta-analysis. BMJ. 2025 Sep 23;390:e084062. doi: 10.1136/bmj-2025-084062.
PubMed 40987514Oikonomou EK, Kokkinidis DG, Kampaktsis PN, Amir EA, Marwick TH, Gupta D, Thavendiranathan P. Assessment of Prognostic Value of Left Ventricular Global Longitudinal Strain for Early Prediction of Chemotherapy-Induced Cardiotoxicity: A Systematic Review and Meta-analysis. JAMA Cardiol. 2019 Oct 1;4(10):1007-1018. doi: 10.1001/jamacardio.2019.2952.
PubMed 31433450Haj-Yehia E, Michel L, Mincu RI, Rassaf T, Totzeck M. Prevention of cancer-therapy related cardiac dysfunction. Curr Heart Fail Rep. 2025 Feb 19;22(1):9. doi: 10.1007/s11897-025-00697-x.
PubMed 39969700