Clinical trial NCT06170580: Improved Image Quality for Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound FLOW Imaging
Official title: Improved Image Quality for Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound FLOW Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Stenosis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
First posted: 2023-12-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 10 patients with and 10 patients without a hemodynamic significant carotid artery stenosis

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 2D velocity vector fields obtained by plane wave and cascaded wave imaging of the carotid artery
timeFrame: After study completion, average of one year
Secondary outcomes:
measure: Signal-to-noise ratio obtained from plane wave and cascaded wave imaging will be obtained and compared for different vessel depths
timeFrame: After study completion, average of one year
measure: Cross-correlation maps of plane wave and cascaded wave imaging will be obtained and compared for different vessel depths
timeFrame: After study completion, average of one year
measure: Velocity vector fields obtained from plane wave and cascaded wave imaging will be obtained and compared
timeFrame: After study completion, average of one year
measure: Blood-flow related parameters, including vector complexity and vorticity, will be calculated from 2D velocity fields.
timeFrame: After study completion, average of one year
measure: Spatiotemporal blood flow profiles obtained with plane wave, cascaded wave and conventional duplex ultrasound will be compared to assess the correlation between these techniques
timeFrame: After study completion, average of one year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
Study officials:
References: