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Quantifying Blood Flow in the Aorta

Quantifying Blood Flow in the Aorta Using Phase-Contrast 4D Flow MRI - Phase 2

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07577752
Acronym
AF-4DMRI-P2
Enrollment
70
Registered
2026-05-11
Start date
2026-06-01
Completion date
2027-07-31
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Aortic Blood Flow

Keywords

Blood flow, Aorta, Magnetic Resonance Imaging, PC 4D-flow MRI, MRI

Brief summary

This study aims to gain insights into aortic blood flow in healthy volunteers using PC 4D-flow MRI

Detailed description

The goal of this observational study is to obtain PC 4D flow MRI scans in seventy healthy volunteers (without any known history of cardiovascular disease) to quantify local blood flow in the thoraco-abdominal aorta and its primary side branches and extract boundary conditions for future in-vitro and in-silico studies. Furthermore, the 3D geometry of the vessels within investigated FOVs, starting from ascending aorta to internal/external iliac arteries, will be obtained by performing a separate MRI sequence. Participants will be asked to undergo MRI scans and are asked to fill out a questionnaire regarding their age, weight, height, and gender. By relating this data to the blood flow patterns observed in the aorta, conclusions can be drawn on the differences in blood flow with gender and how aortic blood flow changes with age.

Interventions

OTHER4D-flow Magnetic Resonance Imaging

Subjects will undergo MRI scans of the thorax and abdomen from which we will derive aortic blood flow velocity fields. This intervention will be performed in the same manner on all groups.

OTHERQuestionnaires

Subjects fill in a questionnaire regarding their weight, height, age and gender. They also fill in a safety check form to test if MRI can be applied safely.

Sponsors

University of Twente
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy (in particular without any cardiovascular disease or history thereof) men or women * 18 years of age or above; * BMI ≤ 30; * Willingness to undergo MRI scans; * Able to provide signed informed consent (IC)

Exclusion criteria

* Irregular heartbeat.; * Any history of cardiovascular disease or current cardiovascular disease; * The standard MRI

Design outcomes

Primary

MeasureTime frameDescription
Aortic blood flow velocity fieldsDay 1Velocity fields will be acquired, consisting of vectors that describe the velocity magnitude (cm/s) and direction (dimensionless) of blood flow in the aorta. For visualisation purposes, arrows will be used to overlay the shape of the volunteers aorta. Colours of the arrrows indicate the velocity magnitude and direction of the arrows inicate the direction of flow. Velocity fields are generated for the the full aorta, from the ascending aorta to internal/external iliac arteries, including branched arteries such as subclavian arteries, common carotid artery, and visceral branch vessels.

Secondary

MeasureTime frameDescription
Turbulent Kinetic EnergyDay 1Turbulent Kinetic Energy (J/kg) is a hemodynamic parameter describing the energy related to the fluctuations in blood flow velocity. This parameter will be extracted from the blood flow velocity vectors in a certain region of interest (e.g. in the ascending aorta, descending aorta, renal arteries, or iliac arteries) and will be plotted over the cardiac cycle.
HelicityDay 1Helicity (m\^4/s\^2) is a hemodynamic parameter that describes how much the blood flow follows a corkscrew-like pattern. This parameter will be extracted from the blood flow velocity vectors in a certain region of interest (e.g. in the ascending aorta, descending aorta, renal arteries, or iliac arteries) and will be plotted over the cardiac cycle.
VorticityDay 1Vorticity (s\^-1) is a hemodynamic parameter that reflects the rotational nature of the blood flow. This parameter will be extracted from the blood flow velocity vectors in a certain region of interest (e.g. in the ascending aorta, descending aorta, renal arteries, or iliac arteries) and will be plotted over the cardiac cycle.
Age of volunteerDay 1Age of volunteer (in years) for division into groups based on gender and age, gathered using a questionnaire.
Gender of volunteerDay 1Gender of volunteer (male/female/other) for division into groups based on gender and age, gathered using a questionnaire.
Height of volunteerDay 1Height (in m) for BMI (in kg/m\^2) calculation, gathered using a questionnaire.
Weight of volunteerDay 1Weight (in kg) for BMI (in kg/m\^2) calculation, gathered using a questionnaire.
Aortic blood flow waveformsDay 1Waveforms will be acquired that show how aortic blood flow in a certain region of interest progresses over the cardiac cycle, presented as plots of velocity magnitude (cm/s) over time (s). Regions of interest are selected in the ascending aorta, descending aorta, carotid arteries, subclavian arteries, renal arteries, suprarenal aorta, abdominal aorta, common iliac arteries, internal iliac arteries, and external iliac arteries.
Wall shear stressDay 1Wall shear stress (Pa) is a hemodynamic parameter expressing the force acting on a certain area of the vessel wall by the flow of blood. This parameter will be extracted from the blood flow velocity vectors in a certain region of interest (e.g. in the ascending aorta, descending aorta, renal arteries, or iliac arteries) and will be plotted over the cardiac cycle.
Kinetic EnergyDay 1Kinetic Energy (J) in the field of fluid mechanics describes the energy related to the flow of blood in a certain region of interest with a certain mass or volume. This parameter will be extracted from the blood flow velocity vectors in a certain region of interest (e.g. in the ascending aorta, descending aorta, renal arteries, or iliac arteries) and will be plotted over the cardiac cycle.
Oscillatory Shear IndexDay 1Oscillatory Shear Index (dimensionless) is a hemodynamic parameter that defines how much the wall shear stress field changes directions over time, which can tell something about whether the forces on the wall (and the flow of blood) are more uniform or more complex. This parameter will be extracted from the blood flow velocity vectors in a certain region of interest (e.g. in the ascending aorta, descending aorta, renal arteries, or iliac arteries) and will be plotted over the cardiac cycle.

Countries

Netherlands

Contacts

CONTACTMarleen E. Krommendijk, ir.
m.e.krommendijk@utwente.nl+31534894988
PRINCIPAL_INVESTIGATORMichel M.P.J. Reijnen, prof. dr.

University of Twente

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026