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

Carotid Artery Stenosis Clinical Trial

— CAS-iFLOW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170580
• Other study ID #: 114554
• Status: Recruiting
• Start date: November 16, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: Anne ECM Saris, PhD
• Phone: +31 (0)24 361 47 30
• Email: Anne.Saris[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic

Intervention

Diagnostic Test:
• Conventional duplex
Conventional carotid duplex measurement
• Ultrasound-based flow imaging using plane wave imaging
Ultrasound-based flow imaging using plane wave imaging
• Ultrasound-based flow imaging using cascaded wave imaging
Ultrasound-based flow imaging using cascaded wave imaging

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Netherlands Organisation for Scientific Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2D velocity vector fields obtained by plane wave and cascaded wave imaging of the carotid artery		After study completion, average of one year
Secondary	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
Secondary	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
Secondary	Velocity vector fields obtained from plane wave and cascaded wave imaging will be obtained and compared		After study completion, average of one year
Secondary	Blood-flow related parameters, including vector complexity and vorticity, will be calculated from 2D velocity fields.		After study completion, average of one year
Secondary	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