Improved Image Quality for Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound FLOW Imaging

Study Overview
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Brief Summary
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Objective: To evaluate the technical performance of a novel cascaded wave imaging technique compared to plane wave imaging for blood flow imaging in patients with and without carotid artery stenosis. Study design: Observational, feasibility study in a total of 10 patients with and 10 patients without a visible carotid artery plaque. Intervention (observational): all participants will undergo a carotid ultrasound measurement including conventional duplex ultrasound and ultrasound based flow imaging using plane waves and cascaded waves.

Official Title
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Improved Image Quality for Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound FLOW Imaging

Conditions
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Carotid Artery Stenosis

Intervention / Treatment
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* Diagnostic Test: Conventional duplex
* Diagnostic Test: Ultrasound-based flow imaging using plane wave imaging
* Diagnostic Test: Ultrasound-based flow imaging using cascaded wave imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capacitated adult male or female (≥18 years old); Informed consent form understood and signed; Recent conventional duplex measurement of the carotid artery confirming either the absence or presence of a plaque Exclusion Criteria: Hampered carotid blood flow imaging during conventional duplex/doppler measurements due to near to total carotid occlusion at the side of interest or a calcified plaque; History of radiation at the head-neck area; Participating in another clinical study, interfering on outcomes.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with carotid artery stenosis<br> | Diagnostic Test: Conventional duplex<br>* Conventional carotid duplex measurement<br>Diagnostic Test: Ultrasound-based flow imaging using plane wave imaging<br>* Ultrasound-based flow imaging using plane wave imaging<br>Diagnostic Test: Ultrasound-based flow imaging using cascaded wave imaging<br>* Ultrasound-based flow imaging using cascaded wave imaging<br>|
| Healthy controls<br>Participants without carotid artery stenosis | Diagnostic Test: Conventional duplex<br>* Conventional carotid duplex measurement<br>Diagnostic Test: Ultrasound-based flow imaging using plane wave imaging<br>* Ultrasound-based flow imaging using plane wave imaging<br>Diagnostic Test: Ultrasound-based flow imaging using cascaded wave imaging<br>* Ultrasound-based flow imaging using cascaded wave imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2D velocity vector fields obtained by plane wave and cascaded wave imaging of the carotid artery |  | After study completion, average of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal-to-noise ratio obtained from plane wave and cascaded wave imaging will be obtained and compared for different vessel depths |  | After study completion, average of one year | 
| Cross-correlation maps of plane wave and cascaded wave imaging will be obtained and compared for different vessel depths |  | After study completion, average of one year | 
| Velocity vector fields obtained from plane wave and cascaded wave imaging will be obtained and compared |  | After study completion, average of one year | 
| Blood-flow related parameters, including vector complexity and vorticity, will be calculated from 2D velocity fields. |  | After study completion, average of one year | 
| Spatiotemporal blood flow profiles obtained with plane wave, cascaded wave and conventional duplex ultrasound will be compared to assess the correlation between these techniques |  | After study completion, average of one year |