Healthy Aortic Blood FlowAF-4DMRI-P2NCT07577752
Quantifying Blood Flow in the Aorta
An observational study of Healthy Aortic Blood Flow, run by University of Twente at 1 site in Netherlands.
Trial summary
This study aims to gain insights into aortic blood flow in healthy volunteers using PC 4D-flow MRI Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aortic Blood Flow
- What is being tested?
- 4D-flow Magnetic Resonance Imaging and Questionnaires
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2026to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects with no known cardiovascular disease or history thereof
Who may be able to join
- 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)
Who cannot join
- Irregular heartbeat.;
- Any history of cardiovascular disease or current cardiovascular disease;
- The standard MRI exclusion criteria (such as pacemakers, cerebral vascular clips, pregnancy, claustrophobia)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
TechMed centre, University of Twente
Enschede, Overijssel, 7522 NH
Cindy D. Lammertink, drs., +31534895350, c.d.lammertink@utwente.nl
Hadi Mirgolbabaee, dr.
About this study
Official title: Quantifying Blood Flow in the Aorta Using Phase-Contrast 4D Flow MRI - Phase 2
This study aims to gain insights into aortic blood flow in healthy volunteers using PC 4D-flow MRI
Read the 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.
- Conditions
- Healthy Aortic Blood Flow
- Being tested
- 4D-flow Magnetic Resonance Imaging, Questionnaires
- Keywords
- Blood flow, Aorta, Magnetic Resonance Imaging, PC 4D-flow MRI, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D-flow Magnetic Resonance ImagingOther
Also called Magnetic Resonance Imaging, Phase contrast MRI, PC-MRI
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.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Five men aged 18-25 and five women aged 18-25 Receives: Other: 4D-flow Magnetic Resonance Imaging; Other: Questionnaires | |
| Group 2 | Five men aged 26-35 and five women aged 26-35 Receives: Other: 4D-flow Magnetic Resonance Imaging; Other: Questionnaires | |
| Group 3 | Five men aged 36-45 and five women aged 36-45 Receives: Other: 4D-flow Magnetic Resonance Imaging; Other: Questionnaires | |
| Group 4 | Five men aged 46-55 and five women aged 46-55 Receives: Other: 4D-flow Magnetic Resonance Imaging; Other: Questionnaires | |
| Group 5 | Five men aged 56-65 and five women aged 56-65 Receives: Other: 4D-flow Magnetic Resonance Imaging; Other: Questionnaires | |
| Group 6 | Five men aged 66-75 and five women aged 66-75 Receives: Other: 4D-flow Magnetic Resonance Imaging; Other: Questionnaires | |
| Group 7 | Five men aged 76-85 and five women aged 76-85 Receives: Other: 4D-flow Magnetic Resonance Imaging; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic blood flow velocity fields
Velocity 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.
Measured: Day 1
Secondary outcomes (11)
Age of volunteer
Age of volunteer (in years) for division into groups based on gender and age, gathered using a questionnaire.
Measured: Day 1
Gender of volunteer
Gender of volunteer (male/female/other) for division into groups based on gender and age, gathered using a questionnaire.
Measured: Day 1
Height of volunteer
Height (in m) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
Measured: Day 1
Weight of volunteer
Weight (in kg) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
Measured: Day 1
Aortic blood flow waveforms
Waveforms 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.
Measured: Day 1
Wall shear stress
Wall 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.
Measured: Day 1
Oscillatory Shear Index
Oscillatory 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.
Measured: Day 1
Kinetic Energy
Kinetic 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.
Measured: Day 1
Turbulent Kinetic Energy
Turbulent 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.
Measured: Day 1
Helicity
Helicity (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.
Measured: Day 1
Vorticity
Vorticity (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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Aortic Blood FlowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marleen Krommendijk, University of Twente
- Investigators
- Michel M.P.J. Reijnen, prof. dr., Principal investigator, University of Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577752
- Sponsor's protocol ID
- AF-4DMRI-P2
- Other IDs
- NL88490.091.25
- Acronym
- AF-4DMRI-P2
- Status last verified
- May 2026
- First submitted
- 17 Mar 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Blood Flow in the Aorta Using Phase-Contrast 4D Flow MRI - Phase 2
- ClinicalTrials.gov ID
- NCT07577752
- Acronym / sponsor ID
- AF-4DMRI-P2 / AF-4DMRI-P2
- Conditions
- Healthy Aortic Blood Flow
- Keywords
- Blood flow, Aorta, Magnetic Resonance Imaging, PC 4D-flow MRI, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of TwenteUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: 4D-flow Magnetic Resonance Imaging, Other: QuestionnairesFive men aged 18-25 and five women aged 18-25 |
| Group 2 | – | Other: 4D-flow Magnetic Resonance Imaging, Other: QuestionnairesFive men aged 26-35 and five women aged 26-35 |
| Group 3 | – | Other: 4D-flow Magnetic Resonance Imaging, Other: QuestionnairesFive men aged 36-45 and five women aged 36-45 |
| Group 4 | – | Other: 4D-flow Magnetic Resonance Imaging, Other: QuestionnairesFive men aged 46-55 and five women aged 46-55 |
| Group 5 | – | Other: 4D-flow Magnetic Resonance Imaging, Other: QuestionnairesFive men aged 56-65 and five women aged 56-65 |
| Group 6 | – | Other: 4D-flow Magnetic Resonance Imaging, Other: QuestionnairesFive men aged 66-75 and five women aged 66-75 |
| Group 7 | – | Other: 4D-flow Magnetic Resonance Imaging, Other: QuestionnairesFive men aged 76-85 and five women aged 76-85 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects with no known cardiovascular disease or history thereof
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Irregular heartbeat.;
- Any history of cardiovascular disease or current cardiovascular disease;
- The standard MRI exclusion criteria (such as pacemakers, cerebral vascular clips, pregnancy, claustrophobia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4D-flow Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging, Phase contrast MRI, PC-MRISubjects 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. | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7 |
| QuestionnairesSubjects 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. | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7 |
Primary outcome
Aortic blood flow velocity fields
Time frame: Day 1
Velocity 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.
11 secondary outcomes
Age of volunteer
Time frame: Day 1
Gender of volunteer
Time frame: Day 1
Height of volunteer
Time frame: Day 1
Weight of volunteer
Time frame: Day 1
Aortic blood flow waveforms
Time frame: Day 1
Wall shear stress
Time frame: Day 1
Oscillatory Shear Index
Time frame: Day 1
Kinetic Energy
Time frame: Day 1
Turbulent Kinetic Energy
Time frame: Day 1
Helicity
Time frame: Day 1
Vorticity
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Aortic Blood Flow
Not yet recruiting
Pilot Clinical Trial of Ultrasound Guided Aortic Compression for Arresting Abdominal Aortic Blood Flow in Healthy Volunteers. This Isn't Device Feasibility, But Rather the Feasibility of a Clinical Maneuver; Specifically, Evaluating Whether the Technique Can Achieve the Anticipated Out
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michel M.P.J. Reijnen, prof. dr. principal investigator
University of Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aortic Blood Flow, run by University of Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marleen E. Krommendijk, ir. (+31534894988, m.e.krommendijk@utwente.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic blood flow velocity fields (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.