NCT06170580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

November 16, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

March 21, 2025

Status Verified

November 1, 2024

Enrollment Period

1.3 years

First QC Date

November 13, 2023

Last Update Submit

March 18, 2025

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

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

    After study completion, average of one year

Secondary Outcomes (5)

  • 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

Study Arms (2)

Participants with a hemodynamic significant carotid artery stenosis

Diagnostic Test: Conventional duplexDiagnostic Test: Ultrasound-based flow imaging using plane wave imagingDiagnostic Test: Ultrasound-based flow imaging using cascaded wave imaging

Participants without a hemodynamic significant carotid artery stenosis

Diagnostic Test: Conventional duplexDiagnostic Test: Ultrasound-based flow imaging using plane wave imagingDiagnostic Test: Ultrasound-based flow imaging using cascaded wave imaging

Interventions

Conventional duplexDIAGNOSTIC_TEST

Conventional carotid duplex measurement

Participants with a hemodynamic significant carotid artery stenosisParticipants without a hemodynamic significant carotid artery stenosis
Ultrasound-based flow imaging using plane wave imagingDIAGNOSTIC_TEST

Ultrasound-based flow imaging using plane wave imaging

Participants with a hemodynamic significant carotid artery stenosisParticipants without a hemodynamic significant carotid artery stenosis
Ultrasound-based flow imaging using cascaded wave imagingDIAGNOSTIC_TEST

Ultrasound-based flow imaging using cascaded wave imaging

Participants with a hemodynamic significant carotid artery stenosisParticipants without a hemodynamic significant carotid artery stenosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud university medical center

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2023

First Posted

December 14, 2023

Study Start

November 16, 2023

Primary Completion

March 10, 2025

Study Completion

March 10, 2025

Last Updated

March 21, 2025

Record last verified: 2024-11

Locations

NL(1)