Improved Image Quality for Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound FLOW Imaging (CAS-iFLOW)

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.

Study Overview

• Status: Completed
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Diagnostic test: Conventional duplex; Diagnostic test: Ultrasound-based flow imaging using plane wave imaging; Diagnostic test: Ultrasound-based flow imaging using cascaded wave imaging

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

10 patients with and 10 patients without a hemodynamic significant carotid artery stenosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with a hemodynamic significant carotid artery stenosis	Diagnostic test: Conventional duplex; Conventional carotid duplex measurement; Diagnostic test: Ultrasound-based flow imaging using plane wave imaging; Ultrasound-based flow imaging using plane wave imaging; Diagnostic test: Ultrasound-based flow imaging using cascaded wave imaging; Ultrasound-based flow imaging using cascaded wave imaging
Participants without a hemodynamic significant carotid artery stenosis	Diagnostic test: Conventional duplex; Conventional carotid duplex measurement; Diagnostic test: Ultrasound-based flow imaging using plane wave imaging; Ultrasound-based flow imaging using plane wave imaging; Diagnostic test: Ultrasound-based flow imaging using cascaded wave imaging; Ultrasound-based flow imaging using cascaded wave imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Netherlands Organisation for Scientific Research

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Actual): March 10, 2025
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Arterial Occlusive Diseases; Carotid Artery Diseases; Constriction, Pathologic; Carotid Stenosis
• Other Study ID Numbers: 114554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No