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Recruiting NCT07577752

Quantifying Blood Flow in the Aorta

— Observational Healthy Aortic Blood Flow

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 4D-flow Magnetic Resonance Imaging, Questionnaires.
Who it may be relevant to
Registry conditions: Healthy Aortic Blood Flow. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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 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.

Primary outcome measures

  • Aortic blood flow velocity fields [Time frame: Day 1]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Netherlands · 1 center
  • TechMed centre, University of Twente — Enschede

Identifiers

NCT: NCT07577752 · AF-4DMRI-P2 · NL88490.091.25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗