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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.

調査の概要

状態

まだ募集していません

研究の種類

観察的

入学 (推定)

14

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Wan Zhang, MD, PhD
  • 電話番号:021-62483180-571401
  • メール:ant0930@163.com

研究場所

    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200040
        • Huadong Hospital, Fudan University
        • コンタクト:
          • Wan Zhang, MD, PhD
          • 電話番号:021-62483180-571401
          • メール:ant0930@163.com
        • 主任研究者:
          • Wan Zhang, MD, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:CASE_CONTROL
  • 時間の展望:RETROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Time-Averaged Wall Shear Stress (TAWSS)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Hemodynamic Response of Time-Averaged Wall Shear Stress (TAWSS) to Changes in Distal Peripheral Resistance
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Wan Zhang, MD, PhD、Huadong Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月1日

一次修了 (推定)

2027年1月1日

研究の完了 (推定)

2027年1月1日

試験登録日

最初に提出

2026年9月28日

QC基準を満たした最初の提出物

2026年10月2日

最初の投稿 (実際)

2026年10月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月6日

QC基準を満たした最後の更新が送信されました

2026年10月2日

最終確認日

2026年10月1日

詳しくは

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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いいえ

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