An observational study in Cardiotoxicity, Thoracic Radiotherapy and Wearable Electronic Devices, sponsored by Yonsei University. Not yet recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by Yonsei University · Observational
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.
"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.
262 studies on the registry are indexed under Cardiotoxicity; 75 are open to participants now.
This study's planned enrollment of 111 is close to the median of 111 across 124 observational studies indexed under Cardiotoxicity.
Browse Cardiotoxicity studies →Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
Incidence of Any-Grade Arrhythmia within 1 Year After Radiotherapy
The proportion of patients experiencing any-grade arrhythmia within 1 year of radiotherapy.
Time frame: Up to 1 year post-radiotherapy
Overall Survival (OS), Cancer-Specific Survival (CSS), and Progression-Free Survival (PFS)
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.
Time frame: Up to 2 years post-radiotherapy
Plan to share: No
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Start is estimated for May 2025; primary completion for Feb 2030, 57 months later.
Of 69 non-industry observational studies under Cardiotoxicity, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 122. This study's planned 57 months is below that.
Counting every sponsor, half of 71 studies reached it within 69 months; a quarter within 33 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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