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Completed

NCT Number: NCT05218421

Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijnstate Hospital, Arnhem, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

Carotid ultrasound

Diagnostic 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 examination

Other

The plaque excised during CEA will be histologically examined to assess the plaque composition, and therefore plaque vulnerability.

Blood Sample Collection

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Association strain and plaque vulnerability

    Time frame: Time Frame: max 2 weeks prior to CEA

    Association between strain parameters and plaque vulnerability (stable versus unstable) quantified by histology staining.

  2. Association shear wave elastography measures and plaque vulnerability

    Time frame: Time Frame: max 2 weeks prior to CEA

    Association between shear wave parameters and plaque vulnerability (stable versus unstable) quantified by histology staining. (only Radboudumc)

  3. Association blood flow-related parameters and plaque vulnerability

    Time frame: Time Frame: max 2 weeks prior to CEA

    Association between blood flow-related parameters, including WSS, vector complexity and vorticity and carotid plaque vulnerability (stable versus unstable) quantified by histology staining.

  4. Comparison predictive value for plaque vulnerability ultrafast imaging techniques vs clinically-used measurements

    Time frame: Time Frame: max 2 weeks prior to CEA

    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.

  5. 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

    Status of 2D blood flow velocity profiles and flow-related parameters (WSS, vector complexity and vorticity) prior- and post-CEA.

  6. Association circulating inflammatory cytokines and plaque vulnerability

    Time frame: Time Frame: During CEA

    Association between the presence of circulating inflammatory cytokines and the degree of plaque vulnerability (as reflected by histology and/or ultrasound)

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Rijnstate Hospital

Registry information

Acronym: CAP-VALUE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2022
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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