NCT06589843

Brief Summary

In this study, patients with chest pain, lung cancer, pulmonary embolism, and routine inpatient physical examination were selected as the research objects, and the experimental design of retrospective cohort study was adopted to carry out artificial intelligence analysis related to pulmonary vascular diseases in patients with multi-dimensional big data. The multi-modal CT acquisition process included plain scan CT(NCCT) and CT pulmonary angiography (CTPA). Ctpa-like image effects can be simulated or reconstructed by non-enhanced plain scan CT images, so that CTPA-like image quality can be obtained without injecting contrast agent. The synthetic CTPA images were further analyzed by artificial intelligence to assist doctors in the intelligent diagnosis of pulmonary vascular diseases.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Sep 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Sep 2024Sep 2029

First Submitted

Initial submission to the registry

September 6, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5 years

First QC Date

September 6, 2024

Last Update Submit

September 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The performance of deep enhanced imaging in lesion detection and diagnosis

    The performance of deep enhanced imaging in lesion detection and diagnosis, including imaging quality, accuracy, sensitivity and specificity in lesion detection and imaging diagnosis.

    2 year

Interventions

Conventional imaging or down-sampling imaging from CT or MR are enhanced by approved deep learning method.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chest pain, lung cancer, pulmonary embolism, and routine inpatient physical examination were studied

You may qualify if:

  • Age ≥18≤100 years old Scan the pulmonary artery and its major branches Patients with suspected pulmonary embolism who received CTPA had a set of CTPA and CT scans The image quality meets the requirements of diagnosis and post-processing Patients who completed the examination in accordance with the data collection criteria Clinical data and follow-up were complete

You may not qualify if:

  • Age \<18 years or age \>100 years The image is incomplete or incorrect Pulmonary artery absent or underenhanced Severe motion artifacts or image noise affect evaluation of pulmonary embolism History of aortic reconstruction, replacement, or stent implantation Congenital variations in the whole or important branches of the aorta in adults (e.g. bovine aortic arch, abnormal right subclavian artery) Severe hypovolemia and hemodynamic instability Severe heart failure with low ejection fraction Dialysis patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Xin Lou

    Chinese PLA General Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman

Study Record Dates

First Submitted

September 6, 2024

First Posted

September 19, 2024

Study Start

September 10, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

September 19, 2024

Record last verified: 2024-09