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OpenTrials
Completed

NCT Number: NCT06170580

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud university medical center

Nijmegen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional duplex

Diagnostic Test

Conventional carotid duplex measurement

Ultrasound-based flow imaging using plane wave imaging

Diagnostic Test

Ultrasound-based flow imaging using plane wave imaging

Ultrasound-based flow imaging using cascaded wave imaging

Diagnostic Test

Ultrasound-based flow imaging using cascaded wave imaging

Primary outcomes

  1. 2D velocity vector fields obtained by plane wave and cascaded wave imaging of the carotid artery

    Time frame: After study completion, average of one year

Secondary outcomes

  1. Signal-to-noise ratio obtained from plane wave and cascaded wave imaging will be obtained and compared for different vessel depths

    Time frame: After study completion, average of one year

  2. Cross-correlation maps of plane wave and cascaded wave imaging will be obtained and compared for different vessel depths

    Time frame: After study completion, average of one year

  3. Velocity vector fields obtained from plane wave and cascaded wave imaging will be obtained and compared

    Time frame: After study completion, average of one year

  4. Blood-flow related parameters, including vector complexity and vorticity, will be calculated from 2D velocity fields.

    Time frame: After study completion, average of one year

  5. Spatiotemporal blood flow profiles obtained with plane wave, cascaded wave and conventional duplex ultrasound will be compared to assess the correlation between these techniques

    Time frame: After study completion, average of one year

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Netherlands Organisation for Scientific Research

Registry information

Acronym: CAS-iFLOW

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 14, 2023
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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