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Hemodynamic Characteristics of Peripheral Arterial Disease Using Computational Fluid Dynamics

2 października 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

14

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Wan Zhang, MD, PhD
  • Numer telefonu: 021-62483180-571401
  • E-mail: ant0930@163.com

Lokalizacje studiów

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chiny, 200040
        • Huadong Hospital, Fudan University
        • Kontakt:
          • Wan Zhang, MD, PhD
          • Numer telefonu: 021-62483180-571401
          • E-mail: ant0930@163.com
        • Główny śledczy:
          • Wan Zhang, MD, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: CASE_CONTROL
  • Perspektywy czasowe: RETROSPECTIVE

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Time-Averaged Wall Shear Stress (TAWSS)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Hemodynamic Response of Time-Averaged Wall Shear Stress (TAWSS) to Changes in Distal Peripheral Resistance
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Wan Zhang, MD, PhD, Huadong Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 listopada 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2027

Ukończenie studiów (Szacowany)

1 stycznia 2027

Daty rejestracji na studia

Pierwszy przesłany

28 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 października 2026

Pierwszy wysłany (Rzeczywisty)

6 października 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 października 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 2026K387

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .