An Integrated System for the Assessment of Carotid Plaque Stability Based on the Artificial Intelligence

NCT04928547 | Unknown

• 1 other identifier: 2020-460-1
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The project will be properly embedded in the clinical practice landscape to both provide a real-world context for research requirements gathering and research result assessment, and a practical application context from the industrial perspective. The landing is planned for cardiology solutions as carotid plaque assessment that can be value-adding features to tackle the current challenges of stroke prediction. The development of stroke prediction model could accelerate the R\&D process and land to key market ultrasound prototypes/products in an agile way. Collaboration and alignment with key market business and R\&D (China Digital Innovation CDI) through workshops and hackathons will be a unique feature of this agile project.

Conditions

Carotid Plaque Stability

Outcome Measures

Primary Outcomes (1)

• Stroke

  3 years

Study Arms (2)

U.S.

Diagnostic Test: Test

MRI

Diagnostic Test: Test

Interventions

Test DIAGNOSTIC_TEST

Different test

MRI; U.S.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to previous research and experience, the percentage of neovascularization grade II and above accounted for about 79% of all plaques in the enrolled patients, neovascularization grade I accounted for 21%, neovascularization grade II predicted the recurrence of stroke in the same basin 10%, neovascularization I The recurrence rate of stroke in the same watershed below grade is 6%, and the sample size is calculated to be about 100 cases. Gray-scale ultrasound shows the presence or absence of hypoechoic and iso-echoic, calcified nodules and other characteristics. The loss to follow-up rate is calculated as 10-15%. This study intends to include 2000 patients with acute anterior circulation ischemic stroke. A total of 100 patients were enrolled in this research center.

You may qualify if:

• Age is greater than or equal to 18 years old and less than or equal to 80 years old;
• At least one imaging examination suggests the presence of carotid artery plaque;
• No allergy and other contraindications to ultrasound contrast;
• Contrast-enhanced ultrasound examination of carotid artery plaque is required;
• Volunteer to join this research project and sign informed consent.

You may not qualify if:

• Patients who are unable to coordinate their body position or hold their breath during the ultrasound examination;
• Patients with severe lack of clinical data;
• During the follow-up, use drugs for the treatment of carotid plaque except lipid-lowering drugs, antiplatelet drugs, antioxidants, and calcium channel blockers;
• Follow up those who have lost contact;
• Ischemic stroke caused by non-carotid artery plaque shedding;
• Patients with atrial fibrillation and other serious heart diseases;
• A history of allergy to ultrasound contrast agents.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 16, 2021
• Study Start: July 15, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2023
• Last Updated: June 16, 2021

Record last verified: 2021-06