NCT06978348

Brief Summary

Establish an artificial intelligence clinical decision support system for patients with carotid/vertebral artery cerebrovascular stenosis, early identification of patients who may have cerebral infarction. With the support of this project, it is expected that a secondary prevention clinical decision support system for chronic stroke will be established, which is likely to become an important auxiliary tool for the management of cerebrovascular diseases in the future.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
244,296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

April 18, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

May 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

April 18, 2025

Last Update Submit

May 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Establish an artificial intelligence clinical decision support system for patients with carotid/vertebral artery cerebrovascular stenosis,Early identification of patients who may have cerebral infarction.

    1.The clinical history, imaging data, blood test indicators and other data of patients who completed carotid/vertebral artery cerebrovascular ultrasound examinations from January 2012 to December 2022 were collected to establish a data set;2. This dataset was statistically analyzed in combination with the general risk factors of cerebrovascular diseases and the specific risk factors of carotid artery stenosis;3. The above-mentioned model was trained using the existing clinical database of patients with carotid and cerebrovascular stenosis in the hospital;4. Through machine learning, an artificial intelligence clinical decision support system for patients with carotid/vertebral artery stenosis is established to identify patients with early cerebrovascular stenosis who require surgical intervention, and even asymptomatic patients.

    December 2025

Secondary Outcomes (1)

  • Analyze the risk factors leading to stroke

    December 2025

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Patients who visited our hospital from January, 2012 to January, 2022; 2. Patients undergoing cervical/vertebral artery cerebrovascular ultrasonography those.

You may qualify if:

  • Patients undergoing vascular (carotid/vertebral artery) B-ultrasound

You may not qualify if:

  • Patients with missing clinical data such as medical history, cerebrovascular ultrasound results and biochemical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Model

Shanghai, Shanghai Municipality, China

RECRUITING

Study Officials

  • Yijun Cheng, Doc

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR
  • Hanbing Shang, Doc

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yijun Cheng, Doc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 18, 2025

First Posted

May 18, 2025

Study Start

May 10, 2025

Primary Completion

June 10, 2025

Study Completion

June 10, 2025

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations