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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05218421
Other study ID # 112669
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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