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

NCT06897189 | Not Yet Recruiting

• 1 other identifier: 4-2024-1631
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiotoxicity; Thoracic Radiotherapy; Wearable Electronic Devices; Thoracic Neoplasms; Atrial Fibrillation

Outcome Measures

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.

  Up to 2 years post-radiotherapy

Secondary Outcomes (6)

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

  p to 2 years post-radiotherapy

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

  Up to 2 years post-radiotherapy

• ypes and Frequency of Arrhythmias Occurring Within 2 Years After Radiotherapy

  Up to 2 years post-radiotherapy

• Incidence of Any-Grade Arrhythmia within 3 Months After Radiotherapy

  Up to 3 months post-radiotherapy

• Incidence of Any-Grade Arrhythmia within 1 Year After Radiotherapy

  Up to 1 year post-radiotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Cardiotoxicity; Thoracic Neoplasms; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Arrhythmias, Cardiac

Central Study Contacts

hong in Yoon, MD

CONTACT

82-2-2228-8110; yhi0225@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): February 16, 2030
• Study Completion (Estimated): February 16, 2030
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)