NCT06897189Not yet recruiting
Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 18 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 111 (estimated)
- First submitted
- 19 Mar 2025
- Start date
- May 2025
- Primary completion date
- 16 Feb 2030
- Lead sponsor
- Yonsei University
- Diseases
- Atrial fibrillation
- NCT number
- NCT06897189
What you commit to
- Study type: Observational
- Planned participants: 111
- From May 2025 to the primary completion date, 16 Feb 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior thoracic radiotherapy
- Classified as low risk for radiation-induced cardiotoxicity per the 2022 ESC guidelines
Other illness
- Pre-existing arrhythmia diagnosed through medical history or pre-treatment evaluation
Other
- Inability to provide informed consent or refusal to participate
- Expected survival ≤ 4 months
- Unsuitability for Wearable CR device use
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.