VFI in Healthy Vessels

May 5, 2023 updated by: Rijnstate Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands
        • Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 71 years (Adult, Older Adult)

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.

Description

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:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Young volunteers
Volunteers with age between 20-30 years
Diagnostic test: Blood speckle tracking
Blood speckle tracking measurements will be acquired of the carotid artery and superficial femoral artery
Diagnostic test: Ultrasound particle Imaging Velocimetry
Ultrasound particle imaging velocimetry will be acquired of the carotid artery and superficial femoral artery
Diagnostic test: 4D flow MRI
4D flow MRI will be acquired of the carotid artery and superficial femoral artery
Diagnostic test: Conventional duplex
Conventional duplex measurements will be acquired of the carotid artery and superficial femoral artery
Old volunteers
Volunteers with age between 65-75 years
Diagnostic test: Blood speckle tracking
Blood speckle tracking measurements will be acquired of the carotid artery and superficial femoral artery
Diagnostic test: Ultrasound particle Imaging Velocimetry
Ultrasound particle imaging velocimetry will be acquired of the carotid artery and superficial femoral artery
Diagnostic test: 4D flow MRI
4D flow MRI will be acquired of the carotid artery and superficial femoral artery
Diagnostic test: Conventional duplex
Conventional duplex measurements will be acquired of the carotid artery and superficial femoral artery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 day (no follow-up)
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
1 day (no follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation VFI techniques (bST vs echoPIV)
Time Frame: 1 day (no follow-up)
Two-dimensional vector velocity fields derived from echoPIV and bST will be used to calculate the spatiotemporal blood flow velocity profiles in the artery
1 day (no follow-up)
Flow derived parameters (WSS)
Time Frame: 1 day (no follow-up)
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.
1 day (no follow-up)
Flow derived parameters (vorticity)
Time Frame: 1 day (no follow-up)
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.
1 day (no follow-up)
Flow derived parameters (vector complexity)
Time Frame: 1 day (no follow-up)
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.
1 day (no follow-up)
Old versus young (blood flow velocity profiles)
Time Frame: 1 day (no follow-up)
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.
1 day (no follow-up)
Old versus young (WSS)
Time Frame: 1 day (no follow-up)
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.
1 day (no follow-up)
Old versus young (vector complexity)
Time Frame: 1 day (no follow-up)
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.
1 day (no follow-up)
Old versus young (vorticity)
Time Frame: 1 day (no follow-up)
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.
1 day (no follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rijnstate Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michel Reijnen, MD, prof, Rijnstate Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL80478.091.22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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