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| Name | Class |
|---|---|
| Korea Health Industry Development Institute | OTHER_GOV |
| VUNO Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From initiation of first chemotherapy up to 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Death from any cause during the follow-up period. | From initiation of first chemotherapy up to 24 months. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33722826 | Background | 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. | |
| 35565449 | Background | Lee 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. |
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Individual participant data will not be shared due to institutional policies and privacy regulations related to the use of retrospective clinical data.
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| 40578470 | Background | Scalia 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. |
| 39488646 | Background | Choi 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. |
| 40765507 | Background | Mihos 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. |
| 40987514 | Background | Gomes 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. |
| 31433450 | Background | Oikonomou 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. |
| 39969700 | Background | Haj-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. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018487 | Ventricular Dysfunction, Left |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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