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Набор скоро начнётся NCT06897189

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

— Наблюдательное Cardiotoxicity Thoracic Radiotherapy Wearable Electronic Devices Thoracic Neoplasms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Cardiotoxicity, Thoracic Radiotherapy, Wearable Electronic Devices, Thoracic Neoplasms. Базовые параметры: от 20 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
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Обзор

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.

Подробное описание

"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.

Первичные конечные точки

  • Incidence of Grade 3 or Higher Atrial Fibrillation (AF) within 2 Years After Radiotherapy [Срок оценки: Up to 2 years post-radiotherapy]
Вторичные конечные точки (6)
  • Incidence of Any-Grade Atrial Fibrillation (AF) within 2 Years After Radiotherapy [Срок оценки: p to 2 years post-radiotherapy]
  • Incidence of Any-Grade Arrhythmia within 2 Years After Radiotherapy [Срок оценки: Up to 2 years post-radiotherapy]
  • ypes and Frequency of Arrhythmias Occurring Within 2 Years After Radiotherapy [Срок оценки: Up to 2 years post-radiotherapy]
  • Incidence of Any-Grade Arrhythmia within 3 Months After Radiotherapy [Срок оценки: Up to 3 months post-radiotherapy]
  • Incidence of Any-Grade Arrhythmia within 1 Year After Radiotherapy [Срок оценки: Up to 1 year post-radiotherapy]
  • Overall Survival (OS), Cancer-Specific Survival (CSS), and Progression-Free Survival (PFS) [Срок оценки: Up to 2 years post-radiotherapy]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 1 центр
  • Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health Syst — Seoul

Идентификаторы

NCT: NCT06897189 · 4-2024-1631

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗