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.
"This prospective observational cohort study aims to assess the risk of radiation-induced arrhythmias in patients undergoing thoracic radiotherapy for solid tumors, integrating real-time cardiac monitoring with wearable cardiac rhythm (Wearable CR) devices and AI-based cardiac substructure segmentation. The study will recruit 111 patients over three years, with a two-year follow-up post-radiotherapy. Patients will undergo Wearable CR monitoring at 3, 12, and 24 months, facilitating early detection and intervention based on standard cardiology guidelines. Radiation dose exposure to key cardiac structures, including the sinoatrial node (SAN) and pulmonary veins (PV), will be analyzed to evaluate correlations with atrial fibrillation (AF) and other arrhythmias. AI-driven segmentation will aid in optimizing dose distribution to minimize cardiotoxicity while maintaining treatment efficacy. The primary endpoint is the incidence of grade 3+ AF within 2 years, with secondary endpoints including any-grade arrhythmia rates, arrhythmia burden, and survival outcomes. All enrolled patients will receive standard radiotherapy protocols tailored to their respective cancer types, ensuring treatment consistency while assessing the impact of radiation on any kinds of cardiotoxicities.
Study Type
OBSERVATIONAL
Enrollment
111
Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System
Seoul, South Korea
Incidence of Grade 3 or Higher Atrial Fibrillation (AF) within 2 Years After Radiotherapy
The proportion of patients who develop Grade 3 or higher atrial fibrillation within 2 years following thoracic radiotherapy.
Time frame: Up to 2 years post-radiotherapy
Incidence of Any-Grade Atrial Fibrillation (AF) within 2 Years After Radiotherapy
The proportion of patients experiencing any grade of atrial fibrillation within 2 years of radiotherapy.
Time frame: p to 2 years post-radiotherapy
Incidence of Any-Grade Arrhythmia within 2 Years After Radiotherapy
The proportion of patients who develop any type of arrhythmia within 2 years of radiotherapy.
Time frame: Up to 2 years post-radiotherapy
ypes and Frequency of Arrhythmias Occurring Within 2 Years After Radiotherapy
Classification and frequency analysis of different types of arrhythmias detected within 2 years after radiotherapy.
Time frame: Up to 2 years post-radiotherapy
Incidence of Any-Grade Arrhythmia within 3 Months After Radiotherapy
The proportion of patients who develop any-grade arrhythmia within 3 months after radiotherapy.
Time frame: Up to 3 months post-radiotherapy
Incidence of Any-Grade Arrhythmia within 1 Year After Radiotherapy
The proportion of patients experiencing any-grade arrhythmia within 1 year of radiotherapy.
Time frame: Up to 1 year post-radiotherapy
Overall Survival (OS), Cancer-Specific Survival (CSS), and Progression-Free Survival (PFS)
Time from radiotherapy to death from any cause, CSS: Time from radiotherapy to death due to cancer, PFS: Time from radiotherapy to disease progression or death from any cause.
Time frame: Up to 2 years post-radiotherapy
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