CardiotoxicityNCT06897189
Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study
An observational study of Cardiotoxicity and Thoracic Radiotherapy, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiotoxicity, Thoracic Radiotherapy, Wearable Electronic Devices
- How many people
- 111 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2025to 16 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System
Seoul
About this 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.
Read the 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.
- Conditions
- Cardiotoxicity, Thoracic Radiotherapy, Wearable Electronic Devices, Thoracic Neoplasms, Atrial Fibrillation
- Medical subject headings
- Cardiotoxicity, Thoracic Neoplasms, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years post-radiotherapy
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study startMay 2025 (estimated)
- Primary completion16 Feb 2030 (estimated)
- Study completion16 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897189
- Sponsor's protocol ID
- 4-2024-1631
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06897189
- Acronym / sponsor ID
- 4-2024-1631
- Conditions
- Cardiotoxicity, Thoracic Radiotherapy, Wearable Electronic Devices, Thoracic Neoplasms, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- 16 Feb 2030 (estimated)
- Study completion
- 16 Feb 2030 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Patients with solid tumors requiring thoracic radiotherapy
- Undergoing curative-intent radiotherapy
- Expected survival > 4 months
- Adults aged ≥ 20 years
- ECOG performance status 0-2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Incidence of Any-Grade Atrial Fibrillation (AF) within 2 Years After Radiotherapy
Time frame: p to 2 years post-radiotherapy
Incidence of Any-Grade Arrhythmia within 2 Years After Radiotherapy
Time frame: Up to 2 years post-radiotherapy
ypes and Frequency of Arrhythmias Occurring Within 2 Years After Radiotherapy
Time frame: Up to 2 years post-radiotherapy
Incidence of 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
Time frame: Up to 1 year post-radiotherapy
Overall Survival (OS), Cancer-Specific Survival (CSS), and Progression-Free Survival (PFS)
Time frame: Up to 2 years post-radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotoxicity and Thoracic Radiotherapy, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hong in Yoon, MD (82-2-2228-8110, yhi0225@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 3 or Higher Atrial Fibrillation (AF) within 2 Years After Radiotherapy (time frame: Up to 2 years post-radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.