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NCT07870512

Carotid Plaque RADS vs CPVH: Diagnostic Accuracy Comparison

Sponsor: Limited Liability Company "European Institute of Family Health"

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2024-05-20

Completion Date

2025-07-20

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Carotid Ultrasound with CPVH and Carotid Plaque RADS Assessment

Duplex ultrasound scanning of carotid arteries followed by two methods of plaque assessment: (1) Carotid Plaque RADS - expert visual classification, and (2) CPVH software - automated virtual histopathology analysis with Prognostic Index calculation

Locations (1)

Limited Liability Company "European Institute of Family Health"

Saint Petersburg, Kolpino, Russia