Important Parameters of NIR-II Imaging in the Early Diagnosis of Lower Extremity Peripheral Artery Disease
NCT Number: NCT06565819
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Peripheral Artery Disease
Interventions: DIAGNOSTIC_TEST: The second near-infrared region (NIR-II) imaging for lower extremity peripheral artery disease (PAD)
Sponsor: Yijie Ning
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2025-12-30
Locations: Full Spectrum Opening in Vivo Fluorescence Imaging System (DPM-IVFM-NIR-OF, Beijing Digital Precision Medicine Technology Co., Ltd., China), Taiyuan, Shanxi, 030000, China

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.

Primary Outcome Measures: Time related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging), In this study, 5-minute NIR-II imaging video of each patient was processed into time-intensity curves to quantify the imaging results. Four time related parameters on time-intensity curves were extracted, including：T start (s), Tmax (s), T 1/2 (s), TR (Time ratio).

Note: "s" is used as the unit "second"., Baseline, 6 months and 1year|Intensity related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging), In this study, 5-minute NIR-II imaging video of each patient was processed into time-intensity curves to quantify the imaging results. Three intensity related parameters on time-intensity curves were extracted, including：Imax (Fi), Ingress (Fi), Engress (Fi).

Note: "Fi" is used as the unit "fluorescence intensity"., Baseline, 6 months and 1year|Time-intensity related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging), In this study, 5-minute NIR-II imaging video of each patient was processed into time-intensity curves to quantify the imaging results. Two time-intensity related parameters on time-intensity curves were extracted, including：Ingress rate (Fi/s), Engress rate (Fi/s).

Note: "s" is used as the unit "second" and "Fi" is used as the unit "fluorescence intensity"., Baseline, 6 months and 1year