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

Plain English Summary

Risk Stratification of Cancer Therapy-Related Cardiac Dysfunction Using AI-Enhanced Electrocardiography is a Not Applicable clinical trial sponsored by Yonsei University studying Cancer Therapy-Related Cardiac Dysfunction, Heart Failure, Left Ventricular Dysfunction. This study uses artificial intelligence (AI) to analyze electrocardiograms (ECG) to predict heart damage in cancer patients before they start treatment. It is for adult cancer patients receiving treatments like anthracyclines, HER2 inhibitors, or immune checkpoint inhibitors who are at risk for heart problems. Participation involves using existing ECG data collected before and after cancer treatment; no new procedures are done. The alternative is current methods of assessing heart risk, which may be less precise than this AI-enhanced approach. The trial aims to enroll 31486 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults (19 years or older) undergoing specific cancer therapies (anthracyclines, HER2 inhibitors, or immune checkpoint inhibitors). Patients must have had an ECG within 90 days before starting cancer treatment. Patients should not have a history of heart failure, cardiomyopathy, or myocarditis, and their heart's pumping function (LVEF) should be 40% or higher before treatment. Patients with certain pre-existing heart conditions or previous use of the specified cancer drugs are excluded. This trial is studying Cancer Therapy-Related Cardiac Dysfunction, Heart Failure, Left Ventricular Dysfunction, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures whether the AI-enhanced ECG can accurately predict the likelihood of developing heart problems within 12 months after cancer therapy, helping doctors manage patient care p The specific primary outcome measures are: Incidence of cancer therapy-related cardiac dysfunction (CTRCD) (From initiation of first chemotherapy up to 24 months.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to provide an early, accessible, and accurate way to identify cancer patients at risk of heart damage from their treatment, filling a gap in current predictive metho This research targets Cancer Therapy-Related Cardiac Dysfunction, Heart Failure, Left Ventricular Dysfunction, where improved treatment options are needed.

Investor Insight

This study signals a growing investment in AI for medical diagnostics, potentially improving patient outcomes and reducing healthcare costs in oncology, with a large market for predictive cardiac tool The large enrollment target of 31486 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your cancer treatment carries a risk of heart problems and how your heart health will be monitored. Inquire if this AI-ECG analysis is being used or considered for your care to assess your heart risk. Understand that your existing ECG data will be analyzed retrospectively to identify potential heart risks. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 31,486 participants

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.

Primary Outcomes

• Incidence of cancer therapy-related cardiac dysfunction (CTRCD) (From initiation of first chemotherapy up to 24 months.)

Secondary Outcomes

• All-cause mortality (From initiation of first chemotherapy up to 24 months.)

Full Eligibility Criteria

Inclusion Criteria:

\- Patients who were prescribed anthracycline (doxorubicin, daunorubicin, epirubicin, aclarubicin, idarubicin), HER2 inhibitor (trastuzumab, emtansine, tucatinib, trastuzumab deruxtecan, pertuzumab), or ICI agents (ipilimumab, nivolumab, atezolizumab, pembrolizumab, durvalumab, avelumab) and have an ECG prescription within 90 days before their first chemotherapy treatment. For trajectory analysis, patients who additionally had an ECG within 90 days after their first chemotherapy treatment were included.

Exclusion Criteria:

\- Patients\<19 years old, patients with a history of heart failure/ cardiomyopathy/myocarditis (confirmed by ICD code), patients with a previous prescription history of the above chemotherapy agents, patients with EF\<40% in echocardiography performed within 1 year before chemotherapy.

Trial Locations

• Severance Hospital, Yonsei University Health System, Seoul, South Korea

Frequently Asked Questions

Related Conditions

• Cancer Therapy-Related Cardiac Dysfunction
• Heart Failure
• Left Ventricular Dysfunction
• Cardiomyopathy
• Myocarditis
• Anthracycline Cardiotoxicity
• Trastuzumab Cardiotoxicity
• Immune Checkpoint Inhibitor Cardiotoxicity
• Oncology
• Cardiology

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