Chinese PE Multimodality Imaging Artificial Intelligence Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorChina-Japan Friendship Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

14 Years and older

Patients suspected of PE

Disqualifiers

Pregnant women

Refuse to follow up

Incomplete or discontinued imaging scans

Insufficient quality of image data to allow for analysis

Trial population

Patients suspected of PE in China

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Artificial Intelligence

    Device

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

Treatment groups

1,500 Participants
are divided into 4 treatment groups
Group A: Acute pulmonary embolism cohort1 intervention
Group B: Chronic thromboembolic pulmonary disease without pulmonary hypertension cohort1 intervention
Group C: Chronic thromboembolic pulmonary hypertension cohort1 intervention
Group D: Other pulmonary vascular disease cohort1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic rate of PE

Comparison before and after AI technique.

Time frame
2 years
2

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

Comparison before and after AI technique.

Time frame
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.

Time frame
2 years
4

30 day mortality

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

Time frame
2 years

Secondary outcomes

1

Rate of discordant PE cases

False positive and false negative rate

Time frame
2 years
2

AI failure rate for PE detection

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

Time frame
2 years
3

12 month mortality

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

Time frame
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.

Time frame
2 years

Other outcomes

Sponsors and contacts

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