Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques

Carotid Artery Plaque Clinical Trial

— CAP-VALUE  

Official title:

Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05218421
• Other study ID #: 112669
• Status: Not yet recruiting
• Start date: February 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Carotid Artery Plaque
• Carotid Stenosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Radboud university medical center	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Time Frame: max 2 weeks prior to CEA
Secondary	Association strain and plaque vulnerability	Association between strain parameters and plaque vulnerability (stable versus unstable) quantified by histology staining.	Time Frame: max 2 weeks prior to CEA
Secondary	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)	Time Frame: max 2 weeks prior to CEA
Secondary	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.	Time Frame: max 2 weeks prior to CEA
Secondary	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.	Time Frame: max 2 weeks prior to CEA
Secondary	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.	Time Frame: max 2 weeks prior to CEA and 6 weeks after CEA
Secondary	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)	Time Frame: During CEA