Quantifying Blood Flow in the Aorta (AF-4DMRI-P2)
2026年5月4日 更新者：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
研究概览
详细说明
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.
研究类型
观察性的
注册 (估计的)
70
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Marleen E. Krommendijk, ir.
- 电话号码：+31534894988
- 邮箱：m.e.krommendijk@utwente.nl
学习地点
-
-
Overijssel
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Enschede、Overijssel、荷兰、7522 NH
- 招聘中
- TechMed centre, University of Twente
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接触：
- Cindy D. Lammertink, drs.
- 电话号码：+31534895350
- 邮箱：c.d.lammertink@utwente.nl
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副研究员：
- Hadi Mirgolbabaee, dr.
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副研究员：
- Marleen E. Krommendijk, ir.
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
Healthy subjects with no known cardiovascular disease or history thereof
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
其他名称：
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.
其他名称：
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.
其他名称：
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.
其他名称：
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.
其他名称：
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.
其他名称：
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.
其他名称：
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Aortic blood flow velocity fields
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Age of volunteer
大体时间：Day 1
|
Age of volunteer (in years) for division into groups based on gender and age, gathered using a questionnaire.
|
Day 1
|
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Gender of volunteer
大体时间：Day 1
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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
大体时间：Day 1
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Height (in m) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
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Day 1
|
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Weight of volunteer
大体时间：Day 1
|
Weight (in kg) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
|
Day 1
|
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Aortic blood flow waveforms
大体时间：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
大体时间：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
大体时间：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.
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Day 1
|
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Kinetic Energy
大体时间：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
大体时间：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
大体时间：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
|
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Vorticity
大体时间：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
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michel M.P.J. Reijnen, prof. dr.、University of Twente
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2026年7月31日
研究完成 (估计的)
2027年7月31日
研究注册日期
首次提交
2026年3月17日
首先提交符合 QC 标准的
2026年5月4日
首次发布 (实际的)
2026年5月11日
研究记录更新
最后更新发布 (实际的)
2026年5月11日
上次提交的符合 QC 标准的更新
2026年5月4日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- AF-4DMRI-P2
- NL88490.091.25 (其他标识符：Centrale Commissie Mensgebonden Onderzoek (CCMO))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.