Status:
NOT_YET_RECRUITING
Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study
Lead Sponsor:
Yonsei University
Conditions:
Cardiotoxicity
Thoracic Radiotherapy
Eligibility:
All Genders
20+ years
Brief Summary
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 usin...
Detailed Description
"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 monit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 16 2030
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT06897189
Start Date
May 1 2025
End Date
February 16 2030
Last Update
April 18 2025
Active Locations (1)
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1
Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System
Seoul, South Korea