Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06170580
Other study ID # 114554
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03931161 - Effect of Evolocumab on Carotid Plaque Composition in Asymptomatic Carotid Artery Stenosis (EVOCAR-1) Phase 4
Recruiting NCT03353103 - Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy Phase 2
Completed NCT03996148 - Time to Post-Anesthesia Neurological Evaluation With Three Different Anesthetic Techniques Phase 4
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Completed NCT00318851 - Carotid Artery Stenting With Protection Registry Phase 3
Completed NCT00597974 - Neurological Outcome With Carotid Artery Stenting N/A
Active, not recruiting NCT05293067 - Troponin In Carotid Revascularization
Completed NCT03133429 - Clinical Study to Evaluate the Safety and Effectiveness of MER® Stents in Carotid Revascularisation. N/A
Recruiting NCT01440036 - The Correlation Between the Enzyme Paraoxigenase 1 (PON1) to Carotid Artery Atheromatous Plaque N/A
Completed NCT00417963 - ViVEXX Carotid Revascularization Trial (VIVA) Phase 3
Completed NCT00177346 - A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection N/A
Recruiting NCT05574972 - Timing Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis(Timing Trial) N/A
Recruiting NCT02476396 - Structural Stability of Carotid Plaque and Symptomatology
Completed NCT05451485 - VFI in Healthy Vessels
Recruiting NCT06033963 - Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy N/A
Not yet recruiting NCT02224209 - Comparison of Staged Angioplasty and Routine Single-stage Stenting (CAS) in the Treatment of Carotid Artery Stenosis Phase 4
Completed NCT02006095 - Neuroimaging Correlates of Memory Decline Following Carotid Interventions
Terminated NCT01236508 - Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease Phase 4
Recruiting NCT05126238 - A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction Phase 3
Recruiting NCT05800821 - Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning