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CompletedNCT05451485Updated May 6, 2023

VFI in Healthy Vessels

An observational study in Carotid Artery Stenosis and Superficial Femoral Artery Stenosis, sponsored by Rijnstate Hospital. Completed at 1 site in Netherlands. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Rijnstate Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
20 Years to 75 Years
Sex
All
01

Study summary

There is a wealth of evidence implicating the important role of blood flow throughout all stages of the process of atherogenesis. Two locations along the vascular tree at which atherosclerotic plaques are typically found are the carotid artery (CA) and the superficial femoral artery (SFA). Nowadays, ultrasound is the technique of choice for assessing the vascular condition in the CA and SFA. However, clinically used ultrasound techniques show a large variability in estimating the blood flow velocity, due to multiple limitations. With the advent of ultrafast ultrasound imaging, (almost) all elements of the transducer can be activated simultaneously. These so-called plane wave acquisition acquires thousands of images per second and makes continuous tracking of blood flow velocities in all directions in the field of view possible. This high-frame-rate acquisition opened up new possibilities for blood flow imaging at the CA and SFA, such as blood Speckle Tracking (bST) and ultrasound Particle Image Velocimetry (echoPIV). Both these vector flow imaging (VFI) techniques enable the quantification of 2D blood flow velocity profiles, where bST uses no contrast agents compared to echoPIV. Beside these novel ultrasound based techniques, 4D Phase Contrast Magnetic Resonance Imaging (4D flow MRI) enables a non-invasive quantification of the 4D blood flow velocity profiles (3D + time) and can be used as reference standard for blood flow assessments in-vivo. We therefore aim to evaluate the performance of both VFI techniques in comparison to 4D flow MRI measurements in the CA and SFA of healthy volunteers.

02

Conditions studied

  • Carotid Artery Stenosis
  • Superficial Femoral Artery Stenosis

Keywords

  • Vector Flow Imaging
  • Ultrasound Particle Image Velocimetry
  • Blood Speckle Tracking
  • 4D flow MR
03

In context

Carotid Stenosis

339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.

This study's enrollment of 20 is below the median of 173 across 144 observational studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study population will include twenty healthy subjects divided in two different age groups.

All volunteers will be recruited within Rijnstate hospital and Radboudumc.

Inclusion criteria

  • Healthy male or female, without cardiovascular and pulmonary medical history and without the use of medication for cardiovascular risk factors
  • Age between 20-30 year or 65-75 years old
  • Willingness to undergo a 4D flow MRI scan and US examinations
  • Informed consent form understood and signed, and agrees to the hospital visit

Exclusion criteria

Exclusion Criteria:

  • Hypersensitivity to the active substance(s) or any of the excipients in Sonovue
  • Pregnancy
  • MRI exclusion criteria (such as presence of pacemaker, cerebral vascular clips, claustrophobia)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Young volunteers

    Volunteers with age between 20-30 years

    Diagnostic Test: Blood speckle tracking · Diagnostic Test: Ultrasound particle Imaging Velocimetry · Diagnostic Test: 4D flow MRI · Diagnostic Test: Conventional duplex

  • Old volunteers

    Volunteers with age between 65-75 years

    Diagnostic Test: Blood speckle tracking · Diagnostic Test: Ultrasound particle Imaging Velocimetry · Diagnostic Test: 4D flow MRI · Diagnostic Test: Conventional duplex

Interventions

  • Diagnostic testBlood speckle tracking

    Blood speckle tracking measurements will be acquired of the carotid artery and superficial femoral artery

  • Diagnostic testUltrasound particle Imaging Velocimetry

    Ultrasound particle imaging velocimetry will be acquired of the carotid artery and superficial femoral artery

  • Diagnostic test4D flow MRI

    4D flow MRI will be acquired of the carotid artery and superficial femoral artery

  • Diagnostic testConventional duplex

    Conventional duplex measurements will be acquired of the carotid artery and superficial femoral artery

06

What researchers measure

Primary outcomes

  1. Validation VFI with MRI (echoPIV)

    Two-dimensional vector velocity fields derived from VFI (echoPIV) and 4D flow MRI will be used to calculate the spatiotemporal blood flow velocity profiles in artery

    Time frame: 1 day (no follow-up)

  2. Validation VFI with MRI (bST)

    Two-dimensional vector velocity fields derived from VFI (bST) and 4D flow MRI will be used to calculate the spatiotemporal blood flow velocity profiles in artery

    Time frame: 1 day (no follow-up)

Secondary outcomes

  1. Correlation VFI techniques (bST vs echoPIV)

    Two-dimensional vector velocity fields derived from echoPIV and bST will be used to calculate the spatiotemporal blood flow velocity profiles in the artery

    Time frame: 1 day (no follow-up)

  2. Flow derived parameters (WSS)

    Two-dimensional vector velocity fields derived from VFI and 4D flow MRI will be used to calculate the flow derived parameters in the artery. Multiple flow derived parameters will be derived from the vector velocity data. One of the flow derived parameters is wall shear stress (WSS), which defines the amount of friction of the blood on the vessel wall.

    Time frame: 1 day (no follow-up)

  3. Flow derived parameters (vorticity)

    Two-dimensional vector velocity fields derived from VFI and 4D flow MRI will be used to calculate the flow derived parameters in the artery. Multiple flow derived parameters will be derived from the vector velocity data. One of the flow derived parameters is the vorticity, or the curl of the velocity. The vorticity represents the rotation of particles inside the flow field. This measure can potentially be used to define regions with disturbed blood flow, as a high value (in rad/s) indicates the occurence of a recirculation.

    Time frame: 1 day (no follow-up)

  4. Flow derived parameters (vector complexity)

    Two-dimensional vector velocity fields derived from VFI and 4D flow MRI will be used to calculate the flow derived parameters in the artery. Multiple flow derived parameters will be derived from the vector velocity data. One of the flow derived parameters is vector complexity, which is a measure of multi-directional flow, ranging from 0 till 1. a value of 1 means complex flow with all velocity vectors pointing in all directions, whereas a value of 0 means laminar flow with all velocity vectors pointing in the same direction. This measure can potentially be used to indicate regions with disturbed blood flow.

    Time frame: 1 day (no follow-up)

  5. Old versus young (blood flow velocity profiles)

    Two-dimensional vector velocity fields derived from VFI and 4D flow MRI will be used to calculate the spatiotemporal blood flow velocity profiles between young and old volunteers.

    Time frame: 1 day (no follow-up)

  6. Old versus young (WSS)

    Two-dimensional vector velocity fields derived from VFI and 4D flow MRI will be used to calculate different flow derived parameters between young and old volunteers. One of the parameters is WSS.

    Time frame: 1 day (no follow-up)

  7. Old versus young (vector complexity)

    Two-dimensional vector velocity fields derived from VFI and 4D flow MRI will be used to calculate different flow derived parameters between young and old volunteers. One of the parameters is vector complexity.

    Time frame: 1 day (no follow-up)

  8. Old versus young (vorticity)

    Two-dimensional vector velocity fields derived from VFI and 4D flow MRI will be used to calculate different flow derived parameters between young and old volunteers. One of the parameters is vorticity.

    Time frame: 1 day (no follow-up)

07

Study locations

1 site
  • Rijnstate Hospital
    Arnhem, Gelderland, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05451485
Lead sponsor
Rijnstate Hospital
Responsible party
Sponsor
First posted
Jul 11, 2022
Start date
Nov 5, 2022
Primary completion
Mar 18, 2023
Completion
Mar 18, 2023
Last update
May 6, 2023

Study contacts

Michel Reijnen, MD, Prof
principal investigator · Rijnstate Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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