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Идёт набор NCT06526468

Chinese PE Multimodality Imaging Artificial Intelligence Study

Наблюдательное Pulmonary Embolism Chronic Thromboembolic Pulmonary Hypertension Chronic Thromboembolic Pulmonary Disease

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
В протоколе указаны: Artificial Intelligence.
Кому может быть актуально
Состояния в реестре: Pulmonary Embolism, Chronic Thromboembolic Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Disease. Базовые параметры: от 14 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

CHinese pulmOnary Embolism Multimodality Imaging-artifiCial intelligencE Study

Обзор

The CHinese pulmOnary Embolism Multimodality Imaging-artifiCial intelligencE Study (CHOICE) is a prospective observational multi-center study that will collect imaging text data and raw data of patients with pulmonary embolism (PE) in China. By combining artificial intelligence technology, it aims to identify imaging markers to assist in early diagnosis, differential diagnosis, risk stratification, and prognosis assessment of PE.

Подробное описание

Pulmonary embolism (PE) represents a significant public health issue. Timely diagnosis and treatment during the acute phase, as well as appropriate long-term follow-up strategies, are crucial for the management of PE. PE is classified into three stages based on disease course: acute pulmonary embolism (APE), chronic thromboembolic pulmonary disease (CTEPD), and chronic thromboembolic pulmonary hypertension (CTEPH). APE can cause acute right ventricular failure and death if not diagnosed and treated early. CTEPD has the potential to significantly impair patients' quality of life. CTEPH is a rare and potentially life-threatening long-term sequelae of PE, characterized by persistent obstruction of pulmonary arteries by organized clots, leading to redistribution of blood flow and secondary remodeling of the pulmonary microvasculature. Early identification of PE and implementation of targeted treatment plans will significantly improve survival rates and prognosis.

Multimodal imaging tests play a crucial role in the management of PE (including computed tomography pulmonary angiography (CTPA), magnetic resonance imaging (MRI), echocardiography, and lung ventilation/perfusion (V/Q) scan). The guidelines have identified the right ventricle to left ventricle (RV:LV) ratio \>1.0 on CTPA or right heart dysfunction signs from echocardiography as important indicators for risk stratification of APE. Patients stratified as high risk require closer monitoring in an inpatient setting. Whereas, those stratified as low risk are suitable for early discharge.

Therefore, exploring novel imaging markers and integrating these markers into radiology reports may have potential clinical significance. If no quantifiable evidence of right ventricular dysfunction is provided to clinicians to make treatment decisions, patients with high-risk APE may be considered "low-risk" and discharged home. In addition, patients with low-risk APE may require longer hospital stays and may not need to be hospitalized, which undoubtedly increases healthcare costs. For patients with CTEPD or CTEPH, treatment options are diverse, including multimodal therapies such as pulmonary endarterectomy, balloon pulmonary angioplasty and targeted medical therapy. Therefore, multimodal imaging evaluation is meaningful for clinical treatment decision-making and efficacy monitoring. Combined with artificial intelligence (AI) technology, it can provide a variety of metrics to assist in evaluating clots morphology, pulmonary ventilation-perfusion function, cardiac function, hemodynamics, and more. AI can not only assist in finding more clinically significant imaging biomarkers but also customize standardized radiology reports, which are expected to address the current challenges.

This study is a multi-center real-world study aimed at exploring novel imaging markers in combination with AI technology and integrating them into a software for clinical application to provide quantitative parameters, using imaging reports and raw data from Chinese patients with PE. It is hypothesized that AI technology can improve early diagnosis, differential diagnosis, risk stratification, and management of PE by increasing the ability to accurately evaluate PE in a real-world clinical setting. The researchers also hypothesized that the integration of AI technologies would be cost-effective and acceptable to radiologists and clinicians.

Вмешательства

  • Устройство Artificial Intelligence
    AI technology will provide novel imaging markers and generate a radiology report with relevant key slice imaging and evaluation results

Первичные конечные точки

  • Diagnostic rate of PE [Срок оценки: 2 years]
  • APE risk stratification rates (low, intermediate low, intermediate high and high risk) [Срок оценки: 2 years]
  • Disease severity of chronic thromboembolic pulmonary disease (CTEPD)/chronic thromboembolic pulmonary hypertension (CTEPH) [Срок оценки: 2 years]
  • 30 day mortality [Срок оценки: 2 years]
Вторичные конечные точки (6)
  • Rate of discordant PE cases [Срок оценки: 2 years]
  • AI failure rate for PE detection [Срок оценки: 2 years]
  • 12 month mortality [Срок оценки: 2 years]
  • Length of hospital stay for PE [Срок оценки: 2 years]
  • Time from symptom onset to final diagnosis [Срок оценки: 3 months]
  • Hospitalization cost for PE using Markov model [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • 14 Years and older
  • Patients suspected of PE

Критерии исключения

  • Pregnant women
  • Refuse to follow up
  • Incomplete or discontinued imaging scans
  • Insufficient quality of image data to allow for analysis

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • China-Japan Frendship hospital — Пекин

Публикации

  • Xi L, Wang J, Liu A, Ni Y, Du J, Huang Q, Li Y, Wen J, Wang H, Zhang S, Zhang Y, Zhang Z, Wang D, Xie W, Gao Q, Cheng Y, Zhai Z, Liu M. Development of a lung perfusion automated quantitative model based on dual-energy CT pulmonary angiography in patients with chronic pulmonary thromboembolism. Insights Imaging. 2025 Aug 18;16(1):182. doi: 10.1186/s13244-025-02067-6. PMID 40825922

Идентификаторы

NCT: NCT06526468 · CHOICE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗