An observational study in Carotid Artery Stenosis Asymptomatic and Carotid Atherosclerosis, sponsored by Limited Liability Company "European Institute of Family Health". Completed at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Limited Liability Company "European Institute of Family Health" · Observational
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.
Carotid atherosclerotic plaques are a major cause of ischemic stroke. Identifying plaques at risk of rupture - so-called "vulnerable" or "unstable" plaques - is critical for guiding treatment decisions, including whether to proceed with surgical intervention (carotid endarterectomy or stenting) or to continue medical therapy.
Currently, ultrasound assessment of plaque morphology relies heavily on the expertise of the examining physician, which introduces subjectivity and variability. The Carotid Plaque RADS system was developed to standardize ultrasound-based plaque classification into categories (2-4) reflecting increasing risk. However, it still depends on visual interpretation by the operator.
The CPVH (Carotid Plaque Virtual Histopathology) software, registered in the Russian Software Registry (Entry No. 33021, April 17, 2026), offers an automated alternative. It performs grey-scale segmentation of ultrasound plaque images to identify five tissue components - blood, lipids, muscle, fibrous tissue, and calcium - and calculates a Prognostic Index (PI, 0-1) along with an automated classification of plaque stability (stable vs. vulnerable).
This prospective, single-center, observational study compares these two methods in a paired design: each plaque is evaluated by both Carotid Plaque RADS (by three independent, blinded experts) and CPVH software. The study includes patients with carotid atherosclerotic plaques of any degree of stenosis (0-99% by NASCET criteria), stratified into four subgroups: stenosis \<20%, 20-49%, 50-69%, and 70-99%.
Primary objective: To evaluate the agreement between Carotid Plaque RADS categories and CPVH Prognostic Index using Spearman correlation, both across the entire sample and within stenosis subgroups.
Secondary objectives:
To assess inter-expert agreement for Carotid Plaque RADS (pairwise Cohen's kappa; overall Fleiss' kappa) To compare the proportion of plaques classified as unstable/vulnerable by each method (McNemar's test) To determine CPVH PI threshold values corresponding to high-risk Carotid Plaque RADS categories (ROC analysis) To evaluate the association of both methods with composite clinical outcomes at 12 months (TIA, ischemic stroke, stenosis progression ≥10%, CEA or stenting) using Kaplan-Meier survival analysis and multivariate Cox regression To identify "gray zones" - cases of inter-method discrepancy - and analyze contributing factors using logistic regression Ultrasound examinations are performed on Logiq E9 and Logiq F8 scanners (General Electric, USA) with multi-frequency linear transducers. Standard duplex scanning includes NASCET-based stenosis assessment, maximum wall thickness measurement, and plaque morphology evaluation.
The pilot sample size is 150 plaques. Clinical outcomes are recorded over a 12-month follow-up period. Statistical analysis is performed using MedCalc for Windows (version 22.023).
The study was approved by the local ethics committee (Protocol No. 1, January 15, 2025). All participants provided written informed consent. Data are anonymized and stored in an electronic database.
257 studies on the registry are indexed under Carotid Artery Diseases; 58 are open to participants now.
This study's enrollment of 150 is below the median of 224 across 112 observational studies indexed under Carotid Artery Diseases.
Browse Carotid Artery Diseases studies →This is the only study on the registry with Limited Liability Company "European Institute of Family Health" as lead sponsor.
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Patients with carotid atherosclerotic plaques of any degree of stenosis referred for duplex ultrasound examination, stratified into four subgroups by degree of stenosis: \<20%, 20-49%, 50-69%, and 70-99%.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with carotid atherosclerotic plaques of any degree of stenosis (0-99% by NASCET criteria), stratified into four subgroups: \<20%, 20-49%, 50-69%, and 70-99%. All plaques are evaluated by both Carotid Plaque RADS (three independent experts) and CPVH software.
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
Agreement between Carotid Plaque RADS and CPVH Prognostic Index
Spearman correlation coefficient between Carotid Plaque RADS categories (2-4) and CPVH Prognostic Index (0-1), assessed across the entire sample and within four stenosis subgroups (\<20%, 20-49%, 50-69%, 70-99%).
Time frame: Baseline (at time of ultrasound examination)
Inter-expert agreement for Carotid Plaque RADS
Pairwise inter-expert agreement assessed by Cohen's kappa; overall agreement across three experts assessed by Fleiss' kappa
Time frame: Baseline
Proportion of plaques classified as vulnerable by each method
Comparison of the proportion of plaques classified as unstable/vulnerable by Carotid Plaque RADS versus CPVH software, assessed by McNemar's test
Time frame: Baseline
CPVH Prognostic Index thresholds for high-risk Carotid Plaque RADS
ROC analysis to determine CPVH Prognostic Index threshold values corresponding to high-risk Carotid Plaque RADS categories (RADS 3 and 4)
Time frame: Baseline
Composite clinical outcome at 12 months
Association of Carotid Plaque RADS categories and CPVH Prognostic Index with composite clinical outcome (TIA, ischemic stroke, stenosis progression ≥10%, carotid endarterectomy or stenting) assessed by Kaplan-Meier survival analysis and multivariate Cox regression
Time frame: 12 months
Inter-method discrepancy analysis
Identification of "gray zone" cases where Carotid Plaque RADS and CPVH disagree on plaque vulnerability, with logistic regression analysis of contributing factors
Time frame: Baseline
Plan to share: No — Due to the pilot nature of this study and participant privacy considerations, individual participant data will not be shared
No publications or documents are linked to this record.
Ran from May 2024 to primary completion in May 2025, 12 months.
Of 50 observational studies under Carotid Artery Diseases, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 94. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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