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
This trial does not accept healthy volunteersQualifiers
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 population
Patients undergoing thoracic radiotherapy for solid tumors with curative intent, aged ≥ 20 years, ECOG 0-2, and at moderate-to-high risk for radiation-induced cardiotoxicity per ESC 2022 guidelines.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
Incidence of Any-Grade Arrhythmia within 3 Months After Radiotherapy
The proportion of patients who develop any-grade arrhythmia within 3 months after radiotherapy.
Sponsors and contacts
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