China-Japan Frendship hospital
Beijing, 100029, China
Location status: Recruiting
Location contact
Min Liu, PhD
CONTACT
Min Liu, PhD
PRINCIPAL_INVESTIGATOR
Zhenguo Zhai, PhD
CONTACT
NCT Number: NCT06526468
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.
Interested in participating?
Request Info14 year and older
All sexes
Observational
Beijing, 100029, China
Location status: Recruiting
Min Liu, PhD
CONTACT
Min Liu, PhD
PRINCIPAL_INVESTIGATOR
Zhenguo Zhai, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AI technology will provide novel imaging markers and generate a radiology report with relevant key slice imaging and evaluation results
Time frame: 2 years
Comparison before and after AI technique.
Time frame: 2 years
Comparison before and after AI technique.
Time frame: 2 years
Comparison before and after AI technique. Assessment of disease severity is comprehensive, referring to the comprehensive risk assessment in pulmonary arterial hypertension (three-strata model) [DOI: 10.1183/13993003.00879-2022], including clinical observations and modifiable variables. The higher the score, the more severe the condition.
Time frame: 2 years
Patient mortality (death) at 30-days post-PE diagnosis. Comparison before and after AI technique.
Time frame: 2 years
False positive and false negative rate
Time frame: 2 years
Proportion of scans unable to be interpreted by AI despite suitable CTPA acquisition
Time frame: 2 years
Patient mortality (death) at 12-months post-PE diagnosis. Comparison before and after AI technique.
Time frame: 2 years
Comparison before and after AI technique. Measured as number of days from admission to time of discharge from hospital.
Time frame: 3 months
Comparison before and after AI technique.
Time frame: 2 years
Comparison before and after AI technique.
Contact information is provided by the study sponsor or research team.
China-Japan Friendship Hospital
Other
CHinese pulmOnary Embolism Multimodality Imaging-artifiCial intelligencE Study
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