VFI in Healthy Vessels

NCT05451485 | Completed

• 1 other identifier: NL80478.091.22
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Artery Stenosis; Superficial Femoral Artery Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (8)

• Correlation VFI techniques (bST vs echoPIV)

  1 day (no follow-up)

• Flow derived parameters (WSS)

  1 day (no follow-up)

• Flow derived parameters (vorticity)

  1 day (no follow-up)

• Flow derived parameters (vector complexity)

  1 day (no follow-up)

• Old versus young (blood flow velocity profiles)

  1 day (no follow-up)

Study Arms (2)

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

Blood speckle tracking DIAGNOSTIC_TEST

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

Old volunteers; Young volunteers

Ultrasound particle Imaging Velocimetry DIAGNOSTIC_TEST

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

Old volunteers; Young volunteers

4D flow MRI DIAGNOSTIC_TEST

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

Old volunteers; Young volunteers

Conventional duplex DIAGNOSTIC_TEST

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

Old volunteers; Young volunteers

Eligibility Criteria

• Age: 20 Years - 75 Years
• Gender Eligibility Details: Both young (n=10) and old (n=10) groups will exist of five female and five male subjects.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Hypersensitivity to the active substance(s) or any of the excipients in Sonovue
• Pregnancy

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 40055083 DERIVED

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michel Reijnen, MD, Prof

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: November 5, 2022
• Primary Completion: March 18, 2023
• Study Completion: March 18, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

NL (1)