NCT07577752

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

March 17, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

Blood flowAortaMagnetic Resonance ImagingPC 4D-flow MRIMRI

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Secondary Outcomes (11)

  • Age of volunteer

    Day 1

  • Gender of volunteer

    Day 1

  • Height of volunteer

    Day 1

  • Weight of volunteer

    Day 1

  • Aortic blood flow waveforms

    Day 1

  • +6 more secondary outcomes

Study Arms (7)

Group 1

Five men aged 18-25 and five women aged 18-25

Other: 4D-flow Magnetic Resonance ImagingOther: Questionnaires

Group 2

Five men aged 26-35 and five women aged 26-35

Other: 4D-flow Magnetic Resonance ImagingOther: Questionnaires

Group 3

Five men aged 36-45 and five women aged 36-45

Other: 4D-flow Magnetic Resonance ImagingOther: Questionnaires

Group 4

Five men aged 46-55 and five women aged 46-55

Other: 4D-flow Magnetic Resonance ImagingOther: Questionnaires

Group 5

Five men aged 56-65 and five women aged 56-65

Other: 4D-flow Magnetic Resonance ImagingOther: Questionnaires

Group 6

Five men aged 66-75 and five women aged 66-75

Other: 4D-flow Magnetic Resonance ImagingOther: Questionnaires

Group 7

Five men aged 76-85 and five women aged 76-85

Other: 4D-flow Magnetic Resonance ImagingOther: Questionnaires

Interventions

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 1Group 2Group 3Group 4Group 5Group 6Group 7

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.

Also known as: Magnetic Resonance Imaging, Phase contrast MRI, PC-MRI
Group 1Group 2Group 3Group 4Group 5Group 6Group 7

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects with no known cardiovascular disease or history thereof

You may qualify if:

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

You may not qualify if:

  • Irregular heartbeat.;
  • Any history of cardiovascular disease or current cardiovascular disease;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TechMed centre, University of Twente

Enschede, Overijssel, 7522 NH, Netherlands

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance SpectroscopySurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Michel M.P.J. Reijnen, prof. dr.

    University of Twente

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marleen E. Krommendijk, ir.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating investigator

Study Record Dates

First Submitted

March 17, 2026

First Posted

May 11, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

May 11, 2026

Record last verified: 2026-05

Locations