About this trial
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 criteria
Qualifiers
Patients with solid tumors requiring thoracic radiotherapy
Undergoing curative-intent radiotherapy
Expected survival > 4 months
Adults aged ≥ 20 years
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed