CAP-VALUE: Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques

Sponsor

Radboud University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05218421

Collaborator

Rijnstate Hospital (Other)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Plaque	Diagnostic Test: Carotid ultrasound Other: Biospecimen collection and examination Other: Blood sample collection

Study Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Diagnostic Test: Carotid ultrasound 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. Other: Biospecimen collection and examination The plaque excised during CEA will be histologically examined to assess the plaque composition, and therefore plaque vulnerability. Other: Blood sample collection 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.

Arm

Intervention/Treatment

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.

Diagnostic Test: Carotid ultrasound

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.

Other: Biospecimen collection and examination

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

Other: Blood sample collection

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.

Outcome Measures

Primary Outcome Measures

Assocation between 2D blood flow velocities and plaque vulnerability [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 Outcome Measures

Association strain and plaque vulnerability [Time Frame: max 2 weeks prior to CEA]
Association between strain parameters and plaque vulnerability (stable versus unstable) quantified by histology staining.
Association shear wave elastography measures and plaque vulnerability [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)
Association blood flow-related parameters and plaque vulnerability [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.
Comparison predictive value for plaque vulnerability ultrafast imaging techniques vs clinically-used measurements [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.
Status 2D blood flow velocity profiles and flow-related parameters prior- and post-CEA [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.
Association circulating inflammatory cytokines and plaque vulnerability [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;