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Hemodynamic Characteristics of Peripheral Arterial Disease Using Computational Fluid Dynamics

2026年10月2日 更新者:Zhijun Bao、Fudan University

Analysis of Hemodynamic Characteristics in Peripheral Arterial Disease Based on Computational Fluid Dynamics

Peripheral arterial disease can reduce blood flow to the legs. This study will examine how blood flow patterns in the leg arteries differ between people with peripheral arterial disease and people without the disease.

Researchers will use existing computed tomography angiography (CTA) images and medical records from participants who previously received CTA as part of routine clinical care. Three-dimensional models of the leg arteries will be created from these images. Computer simulations will then be used to study how changes in blood flow entering the arteries and resistance in smaller downstream blood vessels affect blood flow patterns. The researchers will compare these responses between participants with and without peripheral arterial disease.

This study uses only existing medical records and images. No new participants will be recruited, and no additional examinations or treatments will be performed for research purposes. The goal is to better understand blood flow characteristics associated with peripheral arterial disease.

研究概览

研究类型

观察性的

注册 (估计的)

14

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:Wan Zhang, MD, PhD
  • 电话号码:021-62483180-571401
  • 邮箱:ant0930@163.com

学习地点

    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200040
        • Huadong Hospital, Fudan University
        • 接触:
          • Wan Zhang, MD, PhD
          • 电话号码:021-62483180-571401
          • 邮箱:ant0930@163.com
        • 首席研究员:
          • Wan Zhang, MD, PhD

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adults who underwent lower-extremity computed tomography angiography (CTA) between January 1 and December 31, 2025, and met the eligibility criteria for either the peripheral artery disease (PAD) group or the healthy control group were retrospectively included. One patient-specific bilateral lower-extremity arterial computational fluid dynamics (CFD) model was constructed for each participant, and each participant and corresponding vascular model were treated as one independent study unit.

描述

Inclusion Criteria:

  • Age ≥18 years.
  • Participants who underwent lower-extremity computed tomography angiography (CTA).
  • PAD group: Diagnosis of lower-extremity peripheral artery disease (PAD), defined by a resting ankle-brachial index (ABI) ≤0.90.
  • PAD group: For participants in whom ABI was inconclusive, including ABI >0.90 or ABI >1.40 due to medial arterial calcification, PAD was confirmed by lower-extremity CTA or Doppler ultrasound showing ≥50% arterial stenosis or complete occlusion.
  • Control group: No symptoms suggestive of lower-extremity ischemia and no definite evidence of lower-extremity arterial stenosis or occlusion on CTA; ABI was used when necessary to further exclude PAD.

Exclusion Criteria:

  • History of lower-extremity arterial revascularization.
  • Presence of other diseases that could substantially affect lower-extremity hemodynamics.
  • CTA image quality insufficient for three-dimensional vascular reconstruction.

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

  • 观测模型:CASE_CONTROL
  • 时间观点:RETROSPECTIVE

队列和干预

团体/队列
干预/治疗
PAD Group

Participants with a clinical diagnosis of lower-extremity peripheral arterial disease and available lower-extremity CTA images suitable for patient-specific three-dimensional arterial reconstruction.

Patient-specific three-dimensional lower-extremity arterial models will be reconstructed from existing CTA images and analyzed using computational fluid dynamics (CFD). Two independent single-factor simulation experiments will be performed: an inlet velocity experiment, in which the amplitude of the inlet pulsatile velocity waveform is varied while distal peripheral resistance is held constant, and a peripheral resistance experiment, in which distal peripheral resistance is varied while inlet velocity is held constant. These simulations are performed only on computational models and do not involve any clinical intervention, additional examination, or treatment of participants.

Control Group

Participants without clinical evidence of peripheral arterial disease or significant lower-extremity arterial stenosis and with CTA images suitable for patient-specific three-dimensional arterial reconstruction.

Patient-specific three-dimensional lower-extremity arterial models will be reconstructed from existing CTA images and analyzed using computational fluid dynamics (CFD). Two independent single-factor simulation experiments will be performed: an inlet velocity experiment, in which the amplitude of the inlet pulsatile velocity waveform is varied while distal peripheral resistance is held constant, and a peripheral resistance experiment, in which distal peripheral resistance is varied while inlet velocity is held constant. These simulations are performed only on computational models and do not involve any clinical intervention, additional examination, or treatment of participants.

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
Time-Averaged Wall Shear Stress (TAWSS)
大体时间:During CFD simulation analysis, through January 2027

Time-averaged wall shear stress (TAWSS) will be derived from patient-specific computational fluid dynamics simulations of the lower-extremity arteries. TAWSS will be evaluated across predefined inlet pulsatile velocity and distal peripheral resistance levels. Changes in TAWSS across parameter levels and differences in hemodynamic responses between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Oscillatory Shear Index (OSI)
大体时间:During CFD simulation analysis, through January 2027

Oscillatory shear index (OSI) will be derived from patient-specific computational fluid dynamics simulations of the lower-extremity arteries. OSI will be evaluated across predefined inlet pulsatile velocity and distal peripheral resistance levels. Changes in OSI across parameter levels and differences in hemodynamic responses between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Relative Residence Time (RRT)
大体时间:During CFD simulation analysis, through January 2027

Relative residence time (RRT) will be derived from patient-specific computational fluid dynamics simulations of the lower-extremity arteries. RRT will be evaluated across predefined inlet pulsatile velocity and distal peripheral resistance levels. Changes in RRT across parameter levels and differences in hemodynamic responses between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Endothelial Cell Activation Potential (ECAP)
大体时间:During CFD simulation analysis, through January 2027

Endothelial cell activation potential (ECAP) will be derived from patient-specific computational fluid dynamics simulations of the lower-extremity arteries. ECAP will be evaluated across predefined inlet pulsatile velocity and distal peripheral resistance levels. Changes in ECAP across parameter levels and differences in hemodynamic responses between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Transverse Wall Shear Stress (transWSS)
大体时间:During CFD simulation analysis, through January 2027

Transverse wall shear stress (transWSS) will be derived from patient-specific computational fluid dynamics simulations of the lower-extremity arteries. transWSS will be evaluated across predefined inlet pulsatile velocity and distal peripheral resistance levels. Changes in transWSS across parameter levels and differences in hemodynamic responses between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027

次要结果测量

结果测量
措施说明
大体时间
Hemodynamic Response of Time-Averaged Wall Shear Stress (TAWSS) to Changes in Distal Peripheral Resistance
大体时间:During CFD simulation analysis, through January 2027

Time-averaged wall shear stress (TAWSS) will be evaluated across predefined levels of distal peripheral resistance. Inlet pulsatile velocity will be held constant during the peripheral resistance experiment. Changes in TAWSS across distal peripheral resistance levels and differences in response patterns between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Hemodynamic Response of Oscillatory Shear Index (OSI) to Changes in Distal Peripheral Resistance
大体时间:During CFD simulation analysis, through January 2027

Oscillatory shear index (OSI) will be evaluated across predefined levels of distal peripheral resistance. Inlet pulsatile velocity will be held constant during the peripheral resistance experiment. Changes in OSI across distal peripheral resistance levels and differences in response patterns between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Hemodynamic Response of Relative Residence Time (RRT) to Changes in Distal Peripheral Resistance
大体时间:During CFD simulation analysis, through January 2027

Relative residence time (RRT) will be evaluated across predefined levels of distal peripheral resistance. Inlet pulsatile velocity will be held constant during the peripheral resistance experiment. Changes in RRT across distal peripheral resistance levels and differences in response patterns between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Hemodynamic Response of Endothelial Cell Activation Potential (ECAP) to Changes in Distal Peripheral Resistance
大体时间:During CFD simulation analysis, through January 2027

Endothelial cell activation potential (ECAP) will be evaluated across predefined levels of distal peripheral resistance. Inlet pulsatile velocity will be held constant during the peripheral resistance experiment. Changes in ECAP across distal peripheral resistance levels and differences in response patterns between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Hemodynamic Response of Transverse Wall Shear Stress (transWSS) to Changes in Distal Peripheral Resistance
大体时间:During CFD simulation analysis, through January 2027

Transverse wall shear stress (transWSS) will be evaluated across predefined levels of distal peripheral resistance. Inlet pulsatile velocity will be held constant during the peripheral resistance experiment. Changes in transWSS across distal peripheral resistance levels and differences in response patterns between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Interaction Between Study Group and Hemodynamic Parameter Level for Time-Averaged Wall Shear Stress (TAWSS)
大体时间:During CFD simulation analysis, through January 2027

Group-by-parameter-level interactions will be evaluated for time-averaged wall shear stress (TAWSS) to determine whether the TAWSS response to changes in inlet pulsatile velocity or distal peripheral resistance differs between the PAD and control groups.

During CFD simulation analysis, through January 2027
Interaction Between Study Group and Hemodynamic Parameter Level for Oscillatory Shear Index (OSI)
大体时间:During CFD simulation analysis, through January 2027

Group-by-parameter-level interactions will be evaluated for oscillatory shear index (OSI) to determine whether the OSI response to changes in inlet pulsatile velocity or distal peripheral resistance differs between the PAD and control groups.

During CFD simulation analysis, through January 2027
Interaction Between Study Group and Hemodynamic Parameter Level for Relative Residence Time (RRT)
大体时间:During CFD simulation analysis, through January 2027

Group-by-parameter-level interactions will be evaluated for relative residence time (RRT) to determine whether the RRT response to changes in inlet pulsatile velocity or distal peripheral resistance differs between the PAD and control groups.

During CFD simulation analysis, through January 2027
Interaction Between Study Group and Hemodynamic Parameter Level for Endothelial Cell Activation Potential (ECAP)
大体时间:During CFD simulation analysis, through January 2027

Group-by-parameter-level interactions will be evaluated for endothelial cell activation potential (ECAP) to determine whether the ECAP response to changes in inlet pulsatile velocity or distal peripheral resistance differs between the PAD and control groups.

During CFD simulation analysis, through January 2027
Interaction Between Study Group and Hemodynamic Parameter Level for Transverse Wall Shear Stress (transWSS)
大体时间:During CFD simulation analysis, through January 2027

Group-by-parameter-level interactions will be evaluated for transverse wall shear stress (transWSS) to determine whether the transWSS response to changes in inlet pulsatile velocity or distal peripheral resistance differs between the PAD and control groups.

During CFD simulation analysis, through January 2027
Hemodynamic Response of Time-Averaged Wall Shear Stress (TAWSS) to Changes in Inlet Pulsatile Velocity
大体时间:During CFD simulation analysis, through January 2027

Time-averaged wall shear stress (TAWSS) will be evaluated across predefined levels of inlet pulsatile velocity while distal peripheral resistance is held constant. Changes in TAWSS across inlet pulsatile velocity levels and differences in response patterns between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Hemodynamic Response of Oscillatory Shear Index (OSI) to Changes in Inlet Pulsatile Velocity
大体时间:During CFD simulation analysis, through January 2027

Oscillatory shear index (OSI) will be evaluated across predefined levels of inlet pulsatile velocity while distal peripheral resistance is held constant. Changes in OSI across inlet pulsatile velocity levels and differences in response patterns between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Hemodynamic Response of Relative Residence Time (RRT) to Changes in Inlet Pulsatile Velocity
大体时间:During CFD simulation analysis, through January 2027

Relative residence time (RRT) will be evaluated across predefined levels of inlet pulsatile velocity while distal peripheral resistance is held constant. Changes in RRT across inlet pulsatile velocity levels and differences in response patterns between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Hemodynamic Response of Endothelial Cell Activation Potential (ECAP) to Changes in Inlet Pulsatile Velocity
大体时间:During CFD simulation analysis, through January 2027

Endothelial cell activation potential (ECAP) will be evaluated across predefined levels of inlet pulsatile velocity while distal peripheral resistance is held constant. Changes in ECAP across inlet pulsatile velocity levels and differences in response patterns between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027
Hemodynamic Response of Transverse Wall Shear Stress (transWSS) to Changes in Inlet Pulsatile Velocity
大体时间:During CFD simulation analysis, through January 2027

Transverse wall shear stress (transWSS) will be evaluated across predefined levels of inlet pulsatile velocity while distal peripheral resistance is held constant. Changes in transWSS across inlet pulsatile velocity levels and differences in response patterns between the PAD and control groups will be analyzed.

During CFD simulation analysis, through January 2027

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:Wan Zhang, MD, PhD、Huadong Hospital

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11月1日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年9月28日

首先提交符合 QC 标准的

2026年10月2日

首次发布 (实际的)

2026年10月6日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月2日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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

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