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NCT07870512Completed

Carotid Plaque RADS vs CPVH: Diagnostic Accuracy Comparison

Comparison of Diagnostic Accuracy of the Carotid Plaque RADS System and the Carotid Plaque Virtual Histopathology (CPVH) Software in Assessing the Morphology and Stability of Carotid Atherosclerotic Plaques in All Degrees of Stenosis

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

This study compares two methods for assessing carotid artery plaques - deposits of cholesterol and other substances that can build up in the neck arteries and potentially lead to stroke. The first method, Carotid Plaque RADS, is a standardized ultrasound-based scoring system where expert physicians visually classify plaques into categories reflecting their stability. The second method, CPVH (Carotid Plaque Virtual Histopathology), is a software tool that automatically analyzes ultrasound images to identify plaque components (lipids, fibrous tissue, calcium, blood, muscle) and calculates a prognostic index indicating plaque vulnerability. The study aims to determine how well the results of these two methods agree with each other, whether they identify the same plaques as unstable or vulnerable, and how well each method predicts clinical outcomes such as transient ischemic attack (TIA), ischemic stroke, progression of arterial narrowing, or the need for surgery (carotid endarterectomy or stenting) within a 12-month follow-up period. Patients with carotid atherosclerotic plaques of any degree of severity are included. Plaques are evaluated independently by three ultrasound experts using the Carotid Plaque RADS system and separately by the CPVH software. The results are compared across four groups based on the degree of arterial narrowing: less than 20%, 20-49%, 50-69%, and 70-99%. The study also identifies cases where the two methods disagree and analyzes possible reasons for these discrepancies. The findings are expected to provide practical recommendations for combining both methods in clinical practice, to improve the identification of high-risk plaques and to help personalize treatment decisions for patients with carotid atherosclerosis.

Status (registry)
Completed
Study type
Observational
Enrollment
150 (actual)
First submitted
6 Oct 2026
Start date
20 May 2024
Primary completion date
20 May 2025
Lead sponsor
Limited Liability Company "European Institute of Family Health"
Diseases
Stroke
NCT number
NCT07870512

What you commit to

  • Study type: Observational
  • Participants enrolled: 150
  • From 20 May 2024 to the primary completion date, 20 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior carotid endarterectomy or stenting on the studied side Total occlusion of the carotid artery (100% stenosis) Poor acoustic window precluding adequate ultrasound imaging Inability to provide informed consent

Who the study is looking for

  • Presence of carotid atherosclerotic plaque(s) of any degree of stenosis (0-99% by NASCET criteria) Age 18 years or older Written informed consent obtained

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Limited Liability Company "European Institute of Family Health"
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Saint PetersburgRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.