Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Hemodynamic Characteristics of Peripheral Arterial Disease Using Computational Fluid Dynamics

2. Oktober 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

14

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Wan Zhang, MD, PhD
  • Telefonnummer: 021-62483180-571401
  • E-Mail: ant0930@163.com

Studienorte

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Huadong Hospital, Fudan University
        • Kontakt:
          • Wan Zhang, MD, PhD
          • Telefonnummer: 021-62483180-571401
          • E-Mail: ant0930@163.com
        • Hauptermittler:
          • Wan Zhang, MD, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: CASE_CONTROL
  • Zeitperspektiven: RETROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time-Averaged Wall Shear Stress (TAWSS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hemodynamic Response of Time-Averaged Wall Shear Stress (TAWSS) to Changes in Distal Peripheral Resistance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

  • Hauptermittler: Wan Zhang, MD, PhD, Huadong Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

28. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Oktober 2026

Zuerst gepostet (Tatsächlich)

6. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 2026K387

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .