Carotid Artery PlaqueCAP-VALUENCT05218421
Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques
An observational study of Carotid Artery Plaque, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
Objective: To explore the association between spatio-temporal blood flow velocities (peak systole and end-diastole at prior-stenosis, at maximum stenosis, and post-stenosis) and carotid plaque vulnerability defined by histology staining. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Plaque
- What is being tested?
- Carotid ultrasound, Biospecimen collection and examination and Blood sample collection
- How many people
- 70 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 May 2022to 31 Dec 2025
- 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 a carotid artery stenosis ≥50% according to clinically performed imaging (i.e. duplex, computed tomography angiography (CTA), or magnetic resonance angiography (MRA)) that are scheduled for a CEA.
Who may be able to join
- Presence of carotid artery stenosis (≥50%) according to conventional clinically performed imaging (duplex/CT(A)/MR(A)) and scheduled for a CEA;
- Possibility to perform carotid ultrasound ≤2 weeks before the CEA
- ≥18 years old;
- Able to provide signed or oral informed consent.
Who cannot join
- Hampered carotid blood flow imaging during clinically performed duplex/doppler measurements due to near to total carotid occlusion at the side of interest or a calcified plaque;
- Restenosis after carotid revascularisation at side of interest;
- Participating in another clinical study, interfering on outcomes;
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Rijnstate Hospital
Arnhem
Radboud university medical center
Nijmegen
About this study
Objective: To explore the association between spatio-temporal blood flow velocities (peak systole and end-diastole at prior-stenosis, at maximum stenosis, and post-stenosis) and carotid plaque vulnerability defined by histology staining. Secondary, to assess the association between ultrasound elastography and carotid plaque vulnerability defined by histology staining. Furthermore, to assess the association between blood flow-derived parameters, including wall shear stress (WSS), vector complexity and vorticity, and plaque vulnerability. To evaluate the hemodynamic consequences of a CEA. Last, to explore whether the presence of circulating biomarkers is related to the degree of plaque vulnerability (as reflected by histology and/or ultrasound).
Study design: A multicentre, prospective, observational, cohort study in a total of 70 patients.
Read more
Study population: Patients with a carotid artery stenosis ≥50% according to clinically performed imaging (i.e. duplex, computed tomography angiography (CTA), or magnetic resonance angiography (MRA)) that are scheduled for a CEA.
Intervention (observational): A carotid ultrasound with flow and elastography (strain and shear wave) measurements will be performed maximally 2 weeks prior to the CEA. In the first 20 included patients in the Radboudumc, a 10 mL blood sample will be collected during surgery via the arterial line that is applied for regular care. The plaque excised during CEA will be histologically examined to assess the plaque composition, and therefore plaque vulnerability. Ultrasound-based flow imaging will be repeated six weeks after the CEA to assess the hemodynamic consequences of the CEA procedure. Besides, clinical parameters will be subtracted from electronic health record or, if missing, anamnestically collected from the patient.
Main study parameters/endpoints: Association between 2D spatio-temporal blood flow velocities (peak systole and end-diastole at prior-stenosis, maximum stenosis and post-stenosis), measured by ultrafast ultrasound measurements, and plaque vulnerability (stable versus unstable), defined by histology staining.
- Conditions
- Carotid Artery Plaque
- Being tested
- Carotid ultrasound, Biospecimen collection and examination, Blood sample collection
- Keywords
- Ultrasound, Shear wave elastography, Atherosclerotic plaques, Strain elastography, Ultrafast ultrasound flow imaging, Histological plaque characterization
- Medical subject headings
- Carotid Stenosis, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid ultrasoundDiagnostic test
Carotid ultrasound with flow and elastography (strain and shear wave) measurements will be performed maximally 2 weeks prior to the CEA. Ultrasound-based flow imaging will be repeated six weeks after the CEA to assess the hemodynamic consequences of the CEA procedure.
Biospecimen collection and examinationOther
The plaque excised during CEA will be histologically examined to assess the plaque composition, and therefore plaque vulnerability.
Blood sample collectionOther
In the first 20 included patients in the Radboudumc, a 10 mL blood sample will be collected during surgery via the arterial line that is applied for regular care.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Patients with a carotid artery stenosis ≥50% according to clinically performed imaging (i.e. duplex, computed tomography angiography (CTA), or magnetic resonance angiography (MRA)) that are scheduled for a CEA. Receives: Diagnostic Test: Carotid ultrasound; Other: Biospecimen collection and examination; Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assocation between 2D blood flow velocities and plaque vulnerability
Explore the association between 2D spatio-temporal blood flow velocities (peak systole and end-diastole prior-stenosis, at maximum stenosis and post-stenosis) and atherosclerotic carotid plaque vulnerability (stable versus unstable), defined by histology staining.
Measured: Time Frame: max 2 weeks prior to CEA
Secondary outcomes (6)
Association strain and plaque vulnerability
Association between strain parameters and plaque vulnerability (stable versus unstable) quantified by histology staining.
Measured: Time Frame: max 2 weeks prior to CEA
Association shear wave elastography measures and plaque vulnerability
Association between shear wave parameters and plaque vulnerability (stable versus unstable) quantified by histology staining. (only Radboudumc)
Measured: Time Frame: max 2 weeks prior to CEA
Association blood flow-related parameters and plaque vulnerability
Association between blood flow-related parameters, including WSS, vector complexity and vorticity and carotid plaque vulnerability (stable versus unstable) quantified by histology staining.
Measured: Time Frame: max 2 weeks prior to CEA
Comparison predictive value for plaque vulnerability ultrafast imaging techniques vs clinically-used measurements
Comparison between the predictive value for plaque vulnerability (stable versus unstable) of ultrafast imaging techniques (i.e. flow, strain and shear wave elastography) with that of clinically-used duplex measurements.
Measured: Time Frame: max 2 weeks prior to CEA
Status 2D blood flow velocity profiles and flow-related parameters prior- and post-CEA
Status of 2D blood flow velocity profiles and flow-related parameters (WSS, vector complexity and vorticity) prior- and post-CEA.
Measured: Time Frame: max 2 weeks prior to CEA and 6 weeks after CEA
Association circulating inflammatory cytokines and plaque vulnerability
Association between the presence of circulating inflammatory cytokines and the degree of plaque vulnerability (as reflected by histology and/or ultrasound)
Measured: Time Frame: During CEA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 May 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery PlaqueStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218421
- Sponsor's protocol ID
- 112669
- Acronym
- CAP-VALUE
- Status last verified
- Aug 2026
- First submitted
- 20 Jan 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques
- ClinicalTrials.gov ID
- NCT05218421
- Acronym / sponsor ID
- CAP-VALUE / 112669
- Conditions
- Carotid Artery Plaque
- Keywords
- Ultrasound, Shear wave elastography, Atherosclerotic plaques, Strain elastography, Ultrafast ultrasound flow imaging, Histological plaque characterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Rijnstate Hospital
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 Feb 2022 (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.
Objective: To explore the association between spatio-temporal blood flow velocities (peak systole and end-diastole at prior-stenosis, at maximum stenosis, and post-stenosis) and carotid plaque vulnerability defined by histology staining. Secondary, to assess the association between ultrasound elastography and carotid plaque vulnerability defined by histology staining. Furthermore, to assess the association between blood flow-derived parameters, including wall shear stress (WSS), vector complexity and vorticity, and plaque vulnerability. To evaluate the hemodynamic consequences of a CEA. Last, to explore whether the presence of circulating biomarkers is related to the degree of plaque vulnerability (as reflected by histology and/or ultrasound).
Study design: A multicentre, prospective, observational, cohort study in a total of 70 patients.
Study population: Patients with a carotid artery stenosis ≥50% according to clinically performed imaging (i.e. duplex, computed tomography angiography (CTA), or magnetic resonance angiography (MRA)) that are scheduled for a CEA.
Intervention (observational): A carotid ultrasound with flow and elastography (strain and shear wave) measurements will be performed maximally 2 weeks prior to the CEA. In the first 20 included patients in the Radboudumc, a 10 mL blood sample will be collected during surgery via the arterial line that is applied for regular care. The plaque excised during CEA will be histologically examined to assess the plaque composition, and therefore plaque vulnerability. Ultrasound-based flow imaging will be repeated six weeks after the CEA to assess the hemodynamic consequences of the CEA procedure. Besides, clinical parameters will be subtracted from electronic health record or, if missing, anamnestically collected from the patient.
Main study parameters/endpoints: Association between 2D spatio-temporal blood flow velocities (peak systole and end-diastole at prior-stenosis, maximum stenosis and post-stenosis), measured by ultrafast ultrasound measurements, and plaque vulnerability (stable versus unstable), defined by histology staining.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Diagnostic Test: Carotid ultrasound, Other: Biospecimen collection and examination, Other: Blood sample collectionPatients with a carotid artery stenosis ≥50% according to clinically performed imaging (i.e. duplex, computed tomography angiography (CTA), or magnetic resonance angiography (MRA)) that are scheduled for a CEA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a carotid artery stenosis ≥50% according to clinically performed imaging (i.e. duplex, computed tomography angiography (CTA), or magnetic resonance angiography (MRA)) that are scheduled for a CEA.
Key inclusion criteria (4 listed)
- Presence of carotid artery stenosis (≥50%) according to conventional clinically performed imaging (duplex/CT(A)/MR(A)) and scheduled for a CEA;
- Possibility to perform carotid ultrasound ≤2 weeks before the CEA
- ≥18 years old;
- Able to provide signed or oral informed consent.
Key exclusion criteria (3 listed)
- Hampered carotid blood flow imaging during clinically performed duplex/doppler measurements due to near to total carotid occlusion at the side of interest or a calcified plaque;
- Restenosis after carotid revascularisation at side of interest;
- Participating in another clinical study, interfering on outcomes;
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 ultrasoundCarotid ultrasound with flow and elastography (strain and shear wave) measurements will be performed maximally 2 weeks prior to the CEA. Ultrasound-based flow imaging will be repeated six weeks after the CEA to assess the hemodynamic consequences of the CEA procedure. | Diagnostic test | Participants |
| Biospecimen collection and examinationThe plaque excised during CEA will be histologically examined to assess the plaque composition, and therefore plaque vulnerability. | Other | Participants |
| Blood sample collectionIn the first 20 included patients in the Radboudumc, a 10 mL blood sample will be collected during surgery via the arterial line that is applied for regular care. | Other | Participants |
Primary outcome
Assocation between 2D blood flow velocities and plaque vulnerability
Time frame: Time Frame: max 2 weeks prior to CEA
Explore the association between 2D spatio-temporal blood flow velocities (peak systole and end-diastole prior-stenosis, at maximum stenosis and post-stenosis) and atherosclerotic carotid plaque vulnerability (stable versus unstable), defined by histology staining.
6 secondary outcomes
Association strain and plaque vulnerability
Time frame: Time Frame: max 2 weeks prior to CEA
Association shear wave elastography measures and plaque vulnerability
Time frame: Time Frame: max 2 weeks prior to CEA
Association blood flow-related parameters and plaque vulnerability
Time frame: Time Frame: max 2 weeks prior to CEA
Comparison predictive value for plaque vulnerability ultrafast imaging techniques vs clinically-used measurements
Time frame: Time Frame: max 2 weeks prior to CEA
Status 2D blood flow velocity profiles and flow-related parameters prior- and post-CEA
Time frame: Time Frame: max 2 weeks prior to CEA and 6 weeks after CEA
Association circulating inflammatory cytokines and plaque vulnerability
Time frame: Time Frame: During CEA
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 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Plaque, run by Radboud University Medical Center at 2 sites in Netherlands.
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 4 inclusion and 3 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Assocation between 2D blood flow velocities and plaque vulnerability (time frame: Time Frame: max 2 weeks prior to CEA). 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 19 Aug 2026.