Clinical trial NCT06897189: Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study
Official title: Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiotoxicity
Thoracic Radiotherapy
Wearable Electronic Devices
Thoracic Neoplasms
Atrial Fibrillation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 111
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Grade 3 or Higher Atrial Fibrillation (AF) within 2 Years After Radiotherapy
timeFrame: Up to 2 years post-radiotherapy
Secondary outcomes:
measure: Incidence of Any-Grade Atrial Fibrillation (AF) within 2 Years After Radiotherapy
timeFrame: p to 2 years post-radiotherapy
measure: Incidence of Any-Grade Arrhythmia within 2 Years After Radiotherapy
timeFrame: Up to 2 years post-radiotherapy
measure: ypes and Frequency of Arrhythmias Occurring Within 2 Years After Radiotherapy
timeFrame: Up to 2 years post-radiotherapy
measure: Incidence of Any-Grade Arrhythmia within 3 Months After Radiotherapy
timeFrame: Up to 3 months post-radiotherapy
measure: Incidence of Any-Grade Arrhythmia within 1 Year After Radiotherapy
timeFrame: Up to 1 year post-radiotherapy
measure: Overall Survival (OS), Cancer-Specific Survival (CSS), and Progression-Free Survival (PFS)
timeFrame: Up to 2 years post-radiotherapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System
Study officials:
References: