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Important Parameters of NIR-II Imaging in the Early Diagnosis of Lower Extremity Peripheral Artery Disease

NCT06565819 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-03-19

No results posted yet for this study

Summary

Lower extremity peripheral artery disease (PAD) is a growing global health problem. New ways have been explored to diagnose PAD in recent years, such as the second near-infrared region (NIR-II, 900-1,880 nm wavelengths) imaging. In this study, NIR-II imaging was performed on patients with type 2 diabetes without PAD, and time-intensity curves were generated according to the imaging results, and specific parameters on the curves were analyzed. The key parameters for the diagnosis of lower limb artery plaque were obtained by comparing the parameters of patients with and without plaque. Patients will be followed up six months and one year after the first NIR-II imaging. The patient will undergo Duplex ultrasound (DUS), NIR-II imaging and laboratory examination. With DUS results as the reference standard, patients diagnosed with PAD for the first time during follow-up were focused on, and the parameter range of the first NIR-II imaging was statistically analyzed, so as to obtain the diagnostic threshold for early diagnosis of PAD.

Conditions

Interventions

DIAGNOSTIC_TEST

The second near-infrared region (NIR-II) imaging for lower extremity peripheral artery disease (PAD)

DUS was used as reference criteria to screen out patients newly diagnosed with PAD during follow-up. In this study, NIR-II imaging results of patients at follow-up and initial examination were collected to obtain a threshold for early diagnosis.

Sponsors & Collaborators

  • Yijie Ning

    lead OTHER

Principal Investigators

  • Ruijing Zhang, Doctoral degree · Second Hospital of Shanxi Medical University

  • Honglin Dong, Doctoral degree · Second Hospital of Shanxi Medical University

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06565819 on ClinicalTrials.gov