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NCT07860138
Hemodynamic Characteristics of Peripheral Arterial Disease Using Computational Fluid Dynamics
Conditions: Peripheral Arterial Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 14
Sponsor: Fudan University
Location: Huadong Hospital, Fudan University Shanghai Shanghai Municipality
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07860138). StuddyBuddy aggregates publicly available trial information.