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

4 de mayo de 2026 actualizado por: 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

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

70

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Países Bajos
    • Overijssel
      • Enschede, Overijssel, Países Bajos, 7522 NH
        • Reclutamiento
        • TechMed centre, University of Twente
        • Contacto:
        • Sub-Investigador:
          • Hadi Mirgolbabaee, dr.
        • Sub-Investigador:
          • Marleen E. Krommendijk, ir.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

Healthy subjects with no known cardiovascular disease or history thereof

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Group 1
Five men aged 18-25 and five women aged 18-25
Otro: 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.
Otros nombres:
  • Imagen de resonancia magnética
  • Phase contrast MRI
  • PC-MRI
Otro: 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
Otro: 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.
Otros nombres:
  • Imagen de resonancia magnética
  • Phase contrast MRI
  • PC-MRI
Otro: 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
Otro: 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.
Otros nombres:
  • Imagen de resonancia magnética
  • Phase contrast MRI
  • PC-MRI
Otro: 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
Otro: 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.
Otros nombres:
  • Imagen de resonancia magnética
  • Phase contrast MRI
  • PC-MRI
Otro: 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
Otro: 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.
Otros nombres:
  • Imagen de resonancia magnética
  • Phase contrast MRI
  • PC-MRI
Otro: 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
Otro: 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.
Otros nombres:
  • Imagen de resonancia magnética
  • Phase contrast MRI
  • PC-MRI
Otro: 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
Otro: 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.
Otros nombres:
  • Imagen de resonancia magnética
  • Phase contrast MRI
  • PC-MRI
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Aortic blood flow velocity fields
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Age of volunteer
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 1
Height (in m) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
Day 1
Weight of volunteer
Periodo de tiempo: Day 1
Weight (in kg) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
Day 1
Aortic blood flow waveforms
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Twente

Investigadores

  • Investigador principal: Michel M.P.J. Reijnen, prof. dr., University of Twente

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

31 de julio de 2026

Finalización del estudio (Estimado)

31 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

17 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de mayo de 2026

Publicado por primera vez (Actual)

11 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AF-4DMRI-P2
  • NL88490.091.25 (Otro identificador: Centrale Commissie Mensgebonden Onderzoek (CCMO))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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