Clinical trial · Observational
Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrial Fibrillation | — | UNRESOLVED | — |
| Cardiotoxicity | — | UNRESOLVED | — |
| Thoracic Neoplasms | Thoracic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Thoracic Radiotherapy | — | UNRESOLVED | — |
| Wearable Electronic Devices | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of Grade 3 or Higher Atrial Fibrillation (AF) within 2 Years After Radiotherapy
- timeFrame
- Up to 2 years post-radiotherapy
- description
- The proportion of patients who develop Grade 3 or higher atrial fibrillation within 2 years following thoracic radiotherapy.
Secondary outcomes (6)
- measure
- Incidence of Any-Grade Atrial Fibrillation (AF) within 2 Years After Radiotherapy
- timeFrame
- p to 2 years post-radiotherapy
- description
- The proportion of patients experiencing any grade of atrial fibrillation within 2 years of radiotherapy.
- measure
- Incidence of Any-Grade Arrhythmia within 2 Years After Radiotherapy
- timeFrame
- Up to 2 years post-radiotherapy
- description
- The proportion of patients who develop any type of arrhythmia within 2 years of radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available