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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years post-radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | p to 2 years post-radiotherapy |
| Incidence of Any-Grade Arrhythmia within 2 Years After Radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hong in Yoon, MD | Contact | 82-2-2228-8110 | yhi0225@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System | Seoul | South Korea |
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The proportion of patients who develop any type of arrhythmia within 2 years of radiotherapy. |
| 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. | 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. | 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. | 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. | Up to 2 years post-radiotherapy |
| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D013899 | Thoracic Neoplasms |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001145 | Arrhythmias, Cardiac |
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