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Pulmonary EmbolismNCT06526468

Chinese PE Multimodality Imaging Artificial Intelligence Study

An observational study of Pulmonary Embolism and Chronic Thromboembolic Pulmonary Hypertension, run by China-Japan Friendship Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 14 years and older
What is being tested?
Artificial Intelligence
Type of treatment
Medical device
How many people
1,500 participants
Where
1 siteChina
Study dates
1 Sep 2010to 1 Sep 2028
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 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients suspected of PE in China

Who may be able to join

  • 14 Years and older
  • Patients suspected of PE

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • China-Japan Frendship hospital

    Beijing, 100029

    Min Liu, PhD, +86-10-84205056, mikie0763@126.com

    Zhenguo Zhai, PhD, +86-10-84206269, zhaizhenguo2011@126.com

    Recruiting

Other trials in China

About this study

Official title: CHinese pulmOnary Embolism Multimodality Imaging-artifiCial intelligencE Study

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.

Read the detailed description

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.

Being tested
Artificial Intelligence
Keywords
imaging, early diagnosis, differential diagnosis, risk stratification, prognosis assessment
Medical subject headings
Pulmonary Embolism, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial IntelligenceDevice

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

Study groups in NCT06526468
Study groupRoleWhat they receive
Acute pulmonary embolism cohort1. Patients objectively confirmed acute symptomatic PE or PE with deep vein thrombosis (DVT) 2. PE was confirmed by CTPA, lung V/Q scan or pulmonary angiography.
Receives: Device: Artificial Intelligence
Chronic thromboembolic pulmonary disease without pulmonary hypertension cohort1. Patients with functional impairment despite 3 months of adequate anticoagulation therapy after APE. 2. CTPA/ pulmonary angiography or V/Q scan showed unresolved thrombi in the pulmonary vessels. 3. Without pulmonary hypertension at rest(mean pulmonary arterial pressure (mPAP) <20 mmHg), as measured by right heart catheterization.
Receives: Device: Artificial Intelligence
Chronic thromboembolic pulmonary hypertension cohort1. Patients with functional impairment despite 3 months of adequate anticoagulation therapy 2. CTPA/ pulmonary angiography or V/Q scan showed unresolved thrombi in the pulmonary vessels. 3. With pulmonary hypertension at rest (mean pulmonary arterial pressure (mPAP) >20 mmHg), as measured by right heart catheterization.
Receives: Device: Artificial Intelligence
Other pulmonary vascular disease cohortPatients diagnosed with other pulmonary vascular disease including Takayasu arteritis, pulmonary artery sarcoma, and fibrosing mediastinitis.
Receives: Device: Artificial Intelligence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic rate of PE

    Comparison before and after AI technique.

    Measured: 2 years

  2. APE risk stratification rates (low, intermediate low, intermediate high and high risk)

    Comparison before and after AI technique.

    Measured: 2 years

  3. Disease severity of chronic thromboembolic pulmonary disease (CTEPD)/chronic thromboembolic pulmonary hypertension (CTEPH)

    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.

    Measured: 2 years

  4. 30 day mortality

    Patient mortality (death) at 30-days post-PE diagnosis. Comparison before and after AI technique.

    Measured: 2 years

Secondary outcomes (6)
  1. Rate of discordant PE cases

    False positive and false negative rate

    Measured: 2 years

  2. AI failure rate for PE detection

    Proportion of scans unable to be interpreted by AI despite suitable CTPA acquisition

    Measured: 2 years

  3. 12 month mortality

    Patient mortality (death) at 12-months post-PE diagnosis. Comparison before and after AI technique.

    Measured: 2 years

  4. Length of hospital stay for PE

    Comparison before and after AI technique. Measured as number of days from admission to time of discharge from hospital.

    Measured: 2 years

  5. Time from symptom onset to final diagnosis

    Comparison before and after AI technique.

    Measured: 3 months

  6. Hospitalization cost for PE using Markov model

    Comparison before and after AI technique.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start1 Sep 2010
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

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
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06526468
Sponsor's protocol ID
CHOICE
Status last verified
Aug 2024
First submitted
15 Jun 2024
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Information gathered for this study will not be disclosed to any other person or entity, or for other research.

Publications

  • 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.

    PubMed 40825922

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Embolism and Chronic Thromboembolic Pulmonary Hypertension, run by China-Japan Friendship Hospital at 1 site in China.

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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Aug 2024. 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 China. 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 Min Liu, PhD (+86-10-84205056, mikie0763@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic rate of PE (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06526468, which also lists 1 linked publication.

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 28 Aug 2024.

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