Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques

• Conditions: Carotid Artery Plaque
• Interventions: Diagnostic Test: Carotid ultrasound; Other: Biospecimen collection and examination; Other: Blood sample collection

• Registration Number: NCT05218421
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Last Update Submitted: 2022-01-20
• Study Start: 2022-02-01
• Study First Posted: 2022-02-01
• Last Update Posted: 2022-02-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Biospecimen collection and examination	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.
Participants	Carotid ultrasound	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.
Participants	Blood sample collection	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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)
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.

Trial Locations

Locations (2)

Radboud university medical center; 🇳🇱 Nijmegen, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands