Quantifying Blood Flow in the Aorta (AF-4DMRI-P2)

May 4, 2026 updated by: Marleen Krommendijk, University of Twente

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7522 NH
        • Recruiting
        • TechMed centre, University of Twente
        • Contact:
        • Sub-Investigator:
          • Hadi Mirgolbabaee, dr.
        • Sub-Investigator:
          • Marleen E. Krommendijk, ir.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects with no known cardiovascular disease or history thereof

Description

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 exclusion criteria (such as pacemakers, cerebral vascular clips, pregnancy, claustrophobia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
Five men aged 18-25 and five women aged 18-25
Other: 4D-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.
Other Names:
  • Magnetic Resonance Imaging
  • Phase contrast MRI
  • PC-MRI
Other: Questionnaires
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.
Group 2
Five men aged 26-35 and five women aged 26-35
Other: 4D-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.
Other Names:
  • Magnetic Resonance Imaging
  • Phase contrast MRI
  • PC-MRI
Other: Questionnaires
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.
Group 3
Five men aged 36-45 and five women aged 36-45
Other: 4D-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.
Other Names:
  • Magnetic Resonance Imaging
  • Phase contrast MRI
  • PC-MRI
Other: Questionnaires
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.
Group 4
Five men aged 46-55 and five women aged 46-55
Other: 4D-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.
Other Names:
  • Magnetic Resonance Imaging
  • Phase contrast MRI
  • PC-MRI
Other: Questionnaires
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.
Group 5
Five men aged 56-65 and five women aged 56-65
Other: 4D-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.
Other Names:
  • Magnetic Resonance Imaging
  • Phase contrast MRI
  • PC-MRI
Other: Questionnaires
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.
Group 6
Five men aged 66-75 and five women aged 66-75
Other: 4D-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.
Other Names:
  • Magnetic Resonance Imaging
  • Phase contrast MRI
  • PC-MRI
Other: Questionnaires
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.
Group 7
Five men aged 76-85 and five women aged 76-85
Other: 4D-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.
Other Names:
  • Magnetic Resonance Imaging
  • Phase contrast MRI
  • PC-MRI
Other: Questionnaires
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age of volunteer
Time Frame: Day 1
Age of volunteer (in years) for division into groups based on gender and age, gathered using a questionnaire.
Day 1
Gender of volunteer
Time Frame: Day 1
Gender of volunteer (male/female/other) for division into groups based on gender and age, gathered using a questionnaire.
Day 1
Height of volunteer
Time Frame: Day 1
Height (in m) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
Day 1
Weight of volunteer
Time Frame: Day 1
Weight (in kg) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
Day 1
Aortic blood flow waveforms
Time Frame: Day 1
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.
Day 1
Wall shear stress
Time Frame: Day 1
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.
Day 1
Oscillatory Shear Index
Time Frame: Day 1
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.
Day 1
Kinetic Energy
Time Frame: Day 1
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.
Day 1
Turbulent Kinetic Energy
Time Frame: Day 1
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.
Day 1
Helicity
Time Frame: Day 1
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.
Day 1
Vorticity
Time Frame: Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Twente

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michel M.P.J. Reijnen, prof. dr., University of Twente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AF-4DMRI-P2
  • NL88490.091.25 (Other Identifier: Centrale Commissie Mensgebonden Onderzoek (CCMO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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