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

Completed

• Conditions: Carotid Artery Stenosis
• Interventions: Diagnostic Test: Conventional duplex; Diagnostic Test: Ultrasound-based flow imaging using plane wave imaging; Diagnostic Test: Ultrasound-based flow imaging using cascaded wave imaging

• Registration Number: NCT06170580
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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 hemodynamic significant 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-13
• Study Start: 2023-11-16
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-14
• Status Verified: 2024-11
• Primary Completion: 2025-03-10
• Study Completion: 2025-03-10
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	Ultrasound-based flow imaging using cascaded wave imaging	Participants without carotid artery stenosis
Participants with carotid artery stenosis	Ultrasound-based flow imaging using cascaded wave imaging	-
Healthy controls	Conventional duplex	Participants without carotid artery stenosis
Healthy controls	Ultrasound-based flow imaging using plane wave imaging	Participants without carotid artery stenosis
Participants with carotid artery stenosis	Conventional duplex	-
Participants with carotid artery stenosis	Ultrasound-based flow imaging using plane wave imaging	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Radboud university medical center; 🇳🇱 Nijmegen, Netherlands