VFI in Healthy Vessels

Carotid Artery Stenosis Clinical Trial

Official title:

Vector Flow Imaging in Healthy Vessels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05451485
• Other study ID #: NL80478.091.22
• Status: Completed
• Start date: November 5, 2022
• Est. completion date: March 18, 2023

Study information

• Verified date: May 2023
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 18, 2023
• Est. primary completion date: March 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic
• Superficial Femoral Artery Stenosis

Intervention

Diagnostic Test:
• Blood speckle tracking
Blood speckle tracking measurements will be acquired of the carotid artery and superficial femoral artery
• Ultrasound particle Imaging Velocimetry
Ultrasound particle imaging velocimetry will be acquired of the carotid artery and superficial femoral artery
• 4D flow MRI
4D flow MRI will be acquired of the carotid artery and superficial femoral artery
• Conventional duplex
Conventional duplex measurements will be acquired of the carotid artery and superficial femoral artery

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day (no follow-up)
Primary	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	1 day (no follow-up)
Secondary	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	1 day (no follow-up)
Secondary	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.	1 day (no follow-up)
Secondary	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.	1 day (no follow-up)
Secondary	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.	1 day (no follow-up)
Secondary	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.	1 day (no follow-up)
Secondary	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.	1 day (no follow-up)
Secondary	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.	1 day (no follow-up)
Secondary	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.	1 day (no follow-up)