Carotid Artery StenosisNCT05451485
VFI in Healthy Vessels
An observational study of Carotid Artery Stenosis and Superficial Femoral Artery Stenosis, run by Rijnstate Hospital at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Stenosis, Superficial Femoral Artery Stenosis
- What is being tested?
- Blood speckle tracking, Ultrasound particle Imaging Velocimetry and 4D flow MRI
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Nov 2022to 18 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vector Flow Imaging in Healthy Vessels
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.
- Being tested
- Blood speckle tracking, Ultrasound particle Imaging Velocimetry, 4D flow MRI, Conventional duplex
- Keywords
- Vector Flow Imaging, Ultrasound Particle Image Velocimetry, Blood Speckle Tracking, 4D flow MR
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood speckle trackingDiagnostic test
Blood speckle tracking measurements will be acquired of the carotid artery and superficial femoral artery
Ultrasound particle Imaging VelocimetryDiagnostic test
Ultrasound particle imaging velocimetry will be acquired of the carotid artery and superficial femoral artery
4D flow MRIDiagnostic test
4D flow MRI will be acquired of the carotid artery and superficial femoral artery
Conventional duplexDiagnostic test
Conventional duplex measurements will be acquired of the carotid artery and superficial femoral artery
| Study group | Role | What they receive |
|---|---|---|
| Young volunteers | Volunteers with age between 20-30 years Receives: 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 Receives: Diagnostic Test: Blood speckle tracking; Diagnostic Test: Ultrasound particle Imaging Velocimetry; Diagnostic Test: 4D flow MRI; Diagnostic Test: Conventional duplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day (no follow-up)
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
Measured: 1 day (no follow-up)
Secondary outcomes (8)
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
Measured: 1 day (no follow-up)
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.
Measured: 1 day (no follow-up)
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.
Measured: 1 day (no follow-up)
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.
Measured: 1 day (no follow-up)
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.
Measured: 1 day (no follow-up)
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.
Measured: 1 day (no follow-up)
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.
Measured: 1 day (no follow-up)
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.
Measured: 1 day (no follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start5 Nov 2022
- Primary completion18 Mar 2023
- Study completion18 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Reijnen, MD, Prof, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451485
- Sponsor's protocol ID
- NL80478.091.22
- Status last verified
- May 2023
- First submitted
- 6 Jul 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruisch J, de Bakker JMK, van Helvert M, Schoonbrood MJP, Groot Jebbink E, Holewijn S, Reijnen MMPJ, de Korte CL, Saris AECM. Ultrasound-based Velocity Vector Imaging in the Carotid Bifurcation: Repeatability and an In Vivo Comparison With 4-D Flow MRI. Ultrasound Med Biol. 2025 Jun;51(6):969-976. doi: 10.1016/j.ultrasmedbio.2025.02.008. Epub 2025 Mar 6.
PubMed 40055083
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vector Flow Imaging in Healthy Vessels
- ClinicalTrials.gov ID
- NCT05451485
- Acronym / sponsor ID
- NL80478.091.22
- Keywords
- Vector Flow Imaging, Ultrasound Particle Image Velocimetry, Blood Speckle Tracking, 4D flow MR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 18 Mar 2023 (actual)
- Study completion
- 18 Mar 2023 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young volunteers | – | Diagnostic Test: Blood speckle tracking, Diagnostic Test: Ultrasound particle Imaging Velocimetry, Diagnostic Test: 4D flow MRI, Diagnostic Test: Conventional duplexVolunteers with age between 20-30 years |
| Old volunteers | – | Diagnostic Test: Blood speckle tracking, Diagnostic Test: Ultrasound particle Imaging Velocimetry, Diagnostic Test: 4D flow MRI, Diagnostic Test: Conventional duplexVolunteers with age between 65-75 years |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood speckle trackingBlood speckle tracking measurements will be acquired of the carotid artery and superficial femoral artery | Diagnostic test | Old volunteers, Young volunteers |
| Ultrasound particle Imaging VelocimetryUltrasound particle imaging velocimetry will be acquired of the carotid artery and superficial femoral artery | Diagnostic test | Old volunteers, Young volunteers |
| 4D flow MRI4D flow MRI will be acquired of the carotid artery and superficial femoral artery | Diagnostic test | Old volunteers, Young volunteers |
| Conventional duplexConventional duplex measurements will be acquired of the carotid artery and superficial femoral artery | Diagnostic test | Old volunteers, Young volunteers |
Primary outcome
Validation VFI with MRI (echoPIV)
Time frame: 1 day (no follow-up)
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
Validation VFI with MRI (bST)
Time frame: 1 day (no follow-up)
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
8 secondary outcomes
Correlation VFI techniques (bST vs echoPIV)
Time frame: 1 day (no follow-up)
Flow derived parameters (WSS)
Time frame: 1 day (no follow-up)
Flow derived parameters (vorticity)
Time frame: 1 day (no follow-up)
Flow derived parameters (vector complexity)
Time frame: 1 day (no follow-up)
Old versus young (blood flow velocity profiles)
Time frame: 1 day (no follow-up)
Old versus young (WSS)
Time frame: 1 day (no follow-up)
Old versus young (vector complexity)
Time frame: 1 day (no follow-up)
Old versus young (vorticity)
Time frame: 1 day (no follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 40055083Ruisch J, de Bakker JMK, van Helvert M, Schoonbrood MJP, Groot Jebbink E, Holewijn S, Reijnen MMPJ, de Korte CL, Saris AECM. Ultrasound-based Velocity Vector Imaging in the Carotid Bifurcation: Repeatability and an In Vivo Comparison With 4-D Flow MRI. Ultrasound Med Biol. 2025 Jun;51(6):969-976. doi: 10.1016/j.ultrasmedbio.2025.02.008. Epub 2025 Mar 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Reijnen, MD, Prof principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis and Superficial Femoral Artery Stenosis, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation VFI with MRI (echoPIV) (time frame: 1 day (no follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05451485, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.