Chinese PE Multimodality Imaging Artificial Intelligence Study

NCT06526468 | Recruiting DMC

• 1 other identifier: CHOICE
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pulmonary Embolism; Chronic Thromboembolic Pulmonary Hypertension; Chronic Thromboembolic Pulmonary Disease

Keywords

imaging; early diagnosis; differential diagnosis; risk stratification; prognosis assessment

Outcome Measures

Primary Outcomes (4)

• Diagnostic rate of PE

  Comparison before and after AI technique.

  2 years

• APE risk stratification rates (low, intermediate low, intermediate high and high risk)

  Comparison before and after AI technique.

  2 years

• 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.

  2 years

• 30 day mortality

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

  2 years

Secondary Outcomes (6)

• Rate of discordant PE cases

  2 years

• AI failure rate for PE detection

  2 years

• 12 month mortality

  2 years

• Length of hospital stay for PE

  2 years

• Time from symptom onset to final diagnosis

  3 months

Study Arms (4)

Acute pulmonary embolism cohort

1. 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.

Device: Artificial Intelligence

Chronic thromboembolic pulmonary disease without pulmonary hypertension cohort

1. 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.

Device: Artificial Intelligence

Chronic thromboembolic pulmonary hypertension cohort

1. 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.

Device: Artificial Intelligence

Other pulmonary vascular disease cohort

Patients diagnosed with other pulmonary vascular disease including Takayasu arteritis, pulmonary artery sarcoma, and fibrosing mediastinitis.

Device: Artificial Intelligence

Interventions

Artificial Intelligence DEVICE

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

Acute pulmonary embolism cohort; Chronic thromboembolic pulmonary disease without pulmonary hypertension cohort; Chronic thromboembolic pulmonary hypertension cohort; Other pulmonary vascular disease cohort

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suspected of PE in China

You may qualify if:

• Years and older
• Patients suspected of PE

You may not qualify if:

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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Frendship hospital

Beijing, 100029, China

RECRUITING

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and PEA specimens

MeSH Terms

Conditions

Pulmonary Embolism; Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhenguo Zhai, PhD

  China-Japan Friendship Hospital

  STUDY DIRECTOR

Central Study Contacts

Min Liu, PhD

CONTACT

+86-10-84205056; mikie0763@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: July 29, 2024
• Study Start: September 1, 2010
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)