Clinical trial · Observational
Risk Stratification of Cancer Therapy-Related Cardiac Dysfunction Using AI-Enhanced Electrocardiography
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Therapy-Related Cardiac Dysfunction | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Left Ventricular Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention (retrospective observational study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- High baseline AI-ECG risk for CTRCD
- description
- Patients classified as high risk for CTRCD based on baseline AI-ECG LVSD prediction probability before initiation of cancer therapy.
- interventionNames
- Other: No intervention (retrospective observational study)
- label
- Low baseline AI-ECG risk for CTRCD
- description
- Patients classified as low risk for CTRCD based on baseline AI-ECG LVSD prediction probability before initiation of cancer therapy.
- interventionNames
- Other: No intervention (retrospective observational study)
Primary outcomes (1)
- measure
- Incidence of cancer therapy-related cardiac dysfunction (CTRCD)
- timeFrame
- From initiation of first chemotherapy up to 24 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDStein-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. PMID 33722826
- BACKGROUNDLee 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. PMID 35565449
- BACKGROUNDScalia 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. PMID 40578470
- BACKGROUNDChoi 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. PMID 39488646
- BACKGROUNDMihos 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. PMID 40765507
- BACKGROUNDGomes 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.