Skip to main content
OpenTrials
Completed

NCT Number: NCT05451485

VFI 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carotid Artery Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Superficial Femoral Artery Stenosis Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood speckle tracking

Diagnostic Test

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

Ultrasound particle Imaging Velocimetry

Diagnostic Test

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

4D flow MRI

Diagnostic Test

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

Conventional duplex

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

Vector Flow Imaging in Healthy Vessels

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2022
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.