Carotid Artery Stenosis AsymptomaticCPVH-P-RADSNCT07870512
Carotid Plaque RADS vs CPVH: Diagnostic Accuracy Comparison
An observational study of Carotid Artery Stenosis Asymptomatic and Carotid Atherosclerosis, run by Limited Liability Company "European Institute of Family Health" at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis Asymptomatic, Carotid Atherosclerosis
- What is being tested?
- Carotid Ultrasound with CPVH and Carotid Plaque RADS Assessment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 20 May 2024to 20 Jul 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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%.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Limited Liability Company "European Institute of Family Health"
Saint Petersburg, Kolpino
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Carotid Ultrasound with CPVH and Carotid Plaque RADS Assessment
- Keywords
- Carotid Plaque RADS, CPVH, Virtual Histopathology, Plaque Vulnerability, Ultrasound, Ischemic Stroke, Atherosclerotic Plaque, Prognostic Index
- Medical subject headings
- Carotid Artery Diseases, Ischemic Stroke, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Ultrasound with CPVH and Carotid Plaque RADS AssessmentDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Carotid Atherosclerosis | 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. Receives: Diagnostic Test: Carotid Ultrasound with CPVH and Carotid Plaque RADS Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: Baseline (at time of ultrasound examination)
Secondary outcomes (5)
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start20 May 2024
- Primary completion20 May 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery Stenosis AsymptomaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Limited Liability Company "European Institute of Family Health"
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan N. Umnov, MD, Principal investigator, Limited Liability Company "European Institute of Family Health"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870512
- Sponsor's protocol ID
- CPVH-RADS-2025
- Other IDs
- No. 1 (January 15, 2025)
- Acronym
- CPVH-P-RADS
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the pilot nature of this study and participant privacy considerations, individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07870512
- Acronym / sponsor ID
- CPVH-P-RADS / CPVH-RADS-2025
- Keywords
- Carotid Plaque RADS, CPVH, Virtual Histopathology, Plaque Vulnerability, Ultrasound, Ischemic Stroke, Atherosclerotic Plaque, Prognostic Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Limited Liability Company "European Institute of Family Health"University, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Atherosclerosis | – | Diagnostic Test: Carotid Ultrasound with CPVH and Carotid Plaque RADS AssessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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%.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid Ultrasound with CPVH and Carotid Plaque RADS AssessmentDuplex 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 | Diagnostic test | Carotid Atherosclerosis |
Primary outcome
Agreement between Carotid Plaque RADS and CPVH Prognostic Index
Time frame: Baseline (at time of ultrasound examination)
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%).
5 secondary outcomes
Inter-expert agreement for Carotid Plaque RADS
Time frame: Baseline
Proportion of plaques classified as vulnerable by each method
Time frame: Baseline
CPVH Prognostic Index thresholds for high-risk Carotid Plaque RADS
Time frame: Baseline
Composite clinical outcome at 12 months
Time frame: 12 months
Inter-method discrepancy analysis
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Due to the pilot nature of this study and participant privacy considerations, individual participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan N. Umnov, MD principal investigator
Limited Liability Company "European Institute of Family Health"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis Asymptomatic and Carotid Atherosclerosis, run by Limited Liability Company "European Institute of Family Health" at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between Carotid Plaque RADS and CPVH Prognostic Index (time frame: Baseline (at time of ultrasound examination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.