VFI in Healthy Vessels

NCT ID: NCT05451485

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-05

Study Completion Date

2023-03-18

Brief Summary

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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.

Detailed Description

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Conditions

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Carotid Artery Stenosis Superficial Femoral Artery Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Young volunteers

Volunteers with age between 20-30 years

Blood speckle tracking

Intervention Type DIAGNOSTIC_TEST

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

Ultrasound particle Imaging Velocimetry

Intervention Type DIAGNOSTIC_TEST

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

4D flow MRI

Intervention Type DIAGNOSTIC_TEST

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

Conventional duplex

Intervention Type DIAGNOSTIC_TEST

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

Old volunteers

Volunteers with age between 65-75 years

Blood speckle tracking

Intervention Type DIAGNOSTIC_TEST

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

Ultrasound particle Imaging Velocimetry

Intervention Type DIAGNOSTIC_TEST

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

4D flow MRI

Intervention Type DIAGNOSTIC_TEST

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

Conventional duplex

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Blood speckle tracking

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

Intervention Type DIAGNOSTIC_TEST

Ultrasound particle Imaging Velocimetry

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

Intervention Type DIAGNOSTIC_TEST

4D flow MRI

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

Intervention Type DIAGNOSTIC_TEST

Conventional duplex

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Reijnen, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Locations

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Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 40055083 (View on PubMed)

Other Identifiers

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NL80478.091.22

Identifier Type: -

Identifier Source: org_study_id

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