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VFI in Healthy Vessels

R

Rijnstate Hospital

Status

Completed

Conditions

Superficial Femoral Artery Stenosis
Carotid Artery Stenosis

Treatments

Diagnostic Test: Conventional duplex
Diagnostic Test: Blood speckle tracking
Diagnostic Test: Ultrasound particle Imaging Velocimetry
Diagnostic Test: 4D flow MRI

Study type

Observational

Funder types

Other

Identifiers

NCT05451485
NL80478.091.22

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

20 to 75 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

20 participants in 2 patient groups

Young volunteers
Description:
Volunteers with age between 20-30 years
Treatment:
Diagnostic Test: Ultrasound particle Imaging Velocimetry
Diagnostic Test: Conventional duplex
Diagnostic Test: 4D flow MRI
Diagnostic Test: Blood speckle tracking
Old volunteers
Description:
Volunteers with age between 65-75 years
Treatment:
Diagnostic Test: Ultrasound particle Imaging Velocimetry
Diagnostic Test: Conventional duplex
Diagnostic Test: 4D flow MRI
Diagnostic Test: Blood speckle tracking

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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