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Clinical Trials in South Korea / NCT06897189
Starting soon Observational

Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study

NCT06897189 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2025-05
Last updated
2025-04-18

Condition(s) studied

CardiotoxicityThoracic RadiotherapyWearable Electronic DevicesThoracic NeoplasmsAtrial Fibrillation

Study summary

This prospective observational cohort study aims to assess the risk of radiation-induced cardiotoxicity in patients undergoing thoracic radiotherapy by integrating real-time arrhythmia monitoring using wearable cardiac rehabilitation (wearable CR) devices and AI-based cardiac substructure segmentation. The study will analyze radiation dose exposure to key cardiac structures, including the sinoatrial node (SAN) and pulmonary veins (PV), to identify risk factors for atrial fibrillation (AF) and other arrhythmias. Patients will receive wearable CR monitoring at 3, 12, and 24 months post-radiotherapy, with cardiology follow-up and intervention based on standard clinical guidelines. The study will recruit 111 patients over three years, with a two-year follow-up after radiotherapy. The primary endpoint is the incidence of grade 3+ AF within 2 years, with secondary outcomes including any-grade arrhythmia rates, arrhythmia burden, and survival analysis. By establishing a prospective thoracic radiotherapy patient cohort, this study aims to identify dose-related risk factors, improve early detection and management of radiation-induced arrhythmias, and provide evidence-based strategies to enhance treatment safety and efficacy.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with solid tumors requiring thoracic radiotherapy * Undergoing curative-intent radiotherapy * Expected survival \> 4 months * Adults aged ≥ 20 years * ECOG performance status 0-2 * Classified as moderate-to-high risk for radiation-induced cardiotoxicity per the 2022 ESC guidelines * Able to read, understand, and sign the informed consent form Exclusion Criteria: * History of prior thoracic radiotherapy * Inability to provide informed consent or refusal to participate * Pre-existing arrhythmia diagnosed through medical history or pre-treatment evaluation * Expected survival ≤ 4 months * Classified as low risk for radiation-induced cardiotoxicity per the 2022 ESC guidelines * Unsuitability for Wearable CR device use

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System Seoul South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06897189 on ClinicalTrials.gov ↗ ← All trials in South Korea