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RecruitingNCT06978348Updated May 18, 2025

Research on Early Prediction Model of Ischemic Cerebrovascular Disease Based on Artificial Intelligence Technology.

An observational study in Ischemic Cerebrovascular Disease, Artificial Intelligence and Prediction Model, sponsored by Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by Shanghai Jiao Tong University School of Medicine · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
244,296
Sex
All
01

Study 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.

Read the detailed description

Stroke is a disease with a high mortality rate and incidence rate, and it is one of the main reasons for high medical expenses. Ischemic stroke accounts for approximately 85% of all subtypes of stroke. Carotid artery and vertebral artery stenosis are definite and intervenable risk factors for ischemic stroke. However, the selection of clinical intervention timing and methods for patients with cerebrovascular stenosis is limited to the rate of carotid/vertebral artery stenosis and the symptoms of the patients. Cerebral infarction caused by carotid/vertebral artery stenosis often leads to irreparable neurological deficits. Currently, there is a lack of comprehensive evaluation methods for the severity of ischemic cerebrovascular diseases such as carotid/vertebral artery stenosis, and even less a clinical decision-making system that can predict the progression of the disease. This project intends to take the demographic data and clinical information of patients with cerebrovascular stenosis from multiple centers and ethnic groups as the entry point, combine the multidisciplinary advantages of imaging, ultrasound, clinical medicine and computer science, and use artificial intelligence technology to construct a model for predicting the disease progression and the probability of adverse cardiovascular events such as stroke in patients with cerebrovascular stenosis. Based on this, the investigators' hospital intends to develop a set of secondary prevention management tools and clinical decision support systems for ischemic cerebrovascular diseases.

02

Conditions studied

  • Ischemic Cerebrovascular Disease
  • Artificial Intelligence
  • Prediction Model
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
244,296 participants (estimated)
Patient registry
No
05

What researchers measure

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.

    Time frame: December 2025

Secondary outcomes

  1. Analyze the risk factors leading to stroke

    By collecting the baseline demographic data, clinical history, imaging, laboratory tests and other data of all patients who underwent carotid/vertebral artery vascular ultrasound during the period from 2012.01 to 2022.12, the risk factors causing stroke were analyzed.

    Time frame: December 2025

06

Study locations

1 of 1 sites recruiting
  • Model
    Shanghai, Shanghai, China
    • Yijun Cheng · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06978348
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Yijun Cheng (Principal investigator, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
May 18, 2025
Start date
May 10, 2025
Primary completion
Jun 10, 2025 (estimated)
Completion
Jun 10, 2025 (estimated)
Last update
May 18, 2025

Study contacts

Yijun Cheng, Doc
Contact
cyj12574@rjh.com.cn
86+15021058538
Yijun Cheng, Doc
principal investigator · Ruijin Hospital
Hanbing Shang, Doc
principal investigator · Ruijin Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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