Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorYonsei University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with solid tumors requiring thoracic radiotherapy

Undergoing curative-intent radiotherapy

Expected survival > 4 months

Adults aged ≥ 20 years

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 2 years post-radiotherapy

Secondary outcomes

1

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.

Time frame
p to 2 years post-radiotherapy
2

Incidence of Any-Grade Arrhythmia within 2 Years After Radiotherapy

The proportion of patients who develop any type of arrhythmia within 2 years of radiotherapy.

Time frame
Up to 2 years post-radiotherapy
3

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.

Time frame
Up to 2 years post-radiotherapy
4

Incidence of Any-Grade Arrhythmia within 3 Months After Radiotherapy

The proportion of patients who develop any-grade arrhythmia within 3 months after radiotherapy.

Time frame
Up to 3 months post-radiotherapy

Other outcomes

Sponsors and contacts

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