Quantifying Blood Flow in the Aorta (AF-4DMRI-P2)
4 maj 2026 uppdaterad av: 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
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
70
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Marleen E. Krommendijk, ir.
- Telefonnummer: +31534894988
- E-post: m.e.krommendijk@utwente.nl
Studieorter
-
-
Overijssel
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Enschede, Overijssel, Nederländerna, 7522 NH
- Rekrytering
- TechMed centre, University of Twente
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Kontakt:
- Cindy D. Lammertink, drs.
- Telefonnummer: +31534895350
- E-post: c.d.lammertink@utwente.nl
-
Underutredare:
- Hadi Mirgolbabaee, dr.
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Underutredare:
- Marleen E. Krommendijk, ir.
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Healthy subjects with no known cardiovascular disease or history thereof
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Group 1
Five men aged 18-25 and five women aged 18-25
|
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.
Andra namn:
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
|
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.
Andra namn:
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
|
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.
Andra namn:
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
|
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.
Andra namn:
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
|
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.
Andra namn:
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
|
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.
Andra namn:
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
|
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.
Andra namn:
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Aortic blood flow velocity fields
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Age of volunteer
Tidsram: 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
Tidsram: Day 1
|
Gender of volunteer (male/female/other) for division into groups based on gender and age, gathered using a questionnaire.
|
Day 1
|
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Height of volunteer
Tidsram: Day 1
|
Height (in m) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
|
Day 1
|
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Weight of volunteer
Tidsram: Day 1
|
Weight (in kg) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
|
Day 1
|
|
Aortic blood flow waveforms
Tidsram: 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
|
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Wall shear stress
Tidsram: 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
|
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Oscillatory Shear Index
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Michel M.P.J. Reijnen, prof. dr., University of Twente
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
31 juli 2026
Avslutad studie (Beräknad)
31 juli 2027
Studieregistreringsdatum
Först inskickad
17 mars 2026
Först inskickad som uppfyllde QC-kriterierna
4 maj 2026
Första postat (Faktisk)
11 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AF-4DMRI-P2
- NL88490.091.25 (Annan identifierare: Centrale Commissie Mensgebonden Onderzoek (CCMO))
Plan för individuella deltagardata (IPD)
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