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NCT Number: NCT06897189

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

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.

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Key information

Conditions

Cardiotoxicity Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Thoracic Neoplasms Thoracic Radiotherapy Wearable Electronic Devices Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System

Seoul, South Korea

About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of Grade 3 or Higher Atrial Fibrillation (AF) within 2 Years After Radiotherapy

    Time frame: Up to 2 years post-radiotherapy

    The proportion of patients who develop Grade 3 or higher atrial fibrillation within 2 years following thoracic radiotherapy.

Secondary outcomes

  1. Incidence of Any-Grade Atrial Fibrillation (AF) within 2 Years After Radiotherapy

    Time frame: p to 2 years post-radiotherapy

    The proportion of patients experiencing any grade of atrial fibrillation within 2 years of radiotherapy.

  2. Incidence of Any-Grade Arrhythmia within 2 Years After Radiotherapy

    Time frame: Up to 2 years post-radiotherapy

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

  3. ypes and Frequency of Arrhythmias Occurring Within 2 Years After Radiotherapy

    Time frame: Up to 2 years post-radiotherapy

    Classification and frequency analysis of different types of arrhythmias detected within 2 years after radiotherapy.

  4. Incidence of Any-Grade Arrhythmia within 3 Months After Radiotherapy

    Time frame: Up to 3 months post-radiotherapy

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

  5. Incidence of Any-Grade Arrhythmia within 1 Year After Radiotherapy

    Time frame: Up to 1 year post-radiotherapy

    The proportion of patients experiencing any-grade arrhythmia within 1 year of radiotherapy.

  6. Overall Survival (OS), Cancer-Specific Survival (CSS), and Progression-Free Survival (PFS)

    Time frame: Up to 2 years post-radiotherapy

    Time from radiotherapy to death from any cause, CSS: Time from radiotherapy to death due to cancer, PFS: Time from radiotherapy to disease progression or death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

hong in Yoon, MD

CONTACT

[email protected]

82-2-2228-8110

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Mar 26, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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