Clinical trial NCT05451485: VFI in Healthy Vessels
Official title: Vector Flow Imaging in Healthy Vessels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Stenosis
Superficial Femoral Artery Stenosis
Keywords: Vector Flow Imaging
Ultrasound Particle Image Velocimetry
Blood Speckle Tracking
4D flow MR
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Validation VFI with MRI (echoPIV)
timeFrame: 1 day (no follow-up)
measure: Validation VFI with MRI (bST)
timeFrame: 1 day (no follow-up)
Secondary outcomes:
measure: Correlation VFI techniques (bST vs echoPIV)
timeFrame: 1 day (no follow-up)
measure: Flow derived parameters (WSS)
timeFrame: 1 day (no follow-up)
measure: Flow derived parameters (vorticity)
timeFrame: 1 day (no follow-up)
measure: Flow derived parameters (vector complexity)
timeFrame: 1 day (no follow-up)
measure: Old versus young (blood flow velocity profiles)
timeFrame: 1 day (no follow-up)
measure: Old versus young (WSS)
timeFrame: 1 day (no follow-up)
measure: Old versus young (vector complexity)
timeFrame: 1 day (no follow-up)
measure: Old versus young (vorticity)
timeFrame: 1 day (no follow-up)
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
affiliation: Rijnstate Hospital
name: Michel Reijnen, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: