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

NCT06565819 | Completed DMC

• 1 other identifier: [2024]YX211
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Peripheral Artery Disease

Keywords

Peripheral artery disease; Second near-infrared region imaging

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Patients with type 2 diabetes who had not been diagnosed with lower peripheral artery disease

Patients received NIR-II and DUS six months and one year after the first NIR-II examination

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

Interventions

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

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.

Also known as: Duplex ultrasound (DUS)

Patients with type 2 diabetes who had not been diagnosed with lower peripheral artery disease

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population were inpatients with type 2 diabetes from the Department of Endocrinology, the Second Hospital of Shanxi Medical University.

You may qualify if:

• The subjects are inpatients in the Department of Endocrinology, the Second Hospital of Shanxi Medical University.
• Male or female aged 18-85.
• Patients with type 2 diabetes (WHO 2019 diagnostic criteria).
• The subjects are conscious and fully aware of the research content. They sign the informed consent and agree to participate in the study.

You may not qualify if:

• The patients who have been diagnosed with thyroid disease or are using other drugs that affect metabolism and cannot stop taking them.
• Indocyanine green or iodine allergy
• Previous history of lower limb revascularization surgery or lower limb amputation, or diabetic foot ulcers (current or past).
• Lymphedema, thrombophlebitis, deep vein thrombosis (current or past 6 months).
• Patients with acute infections, tumors, severe arrhythmias, psychiatric disorders, drug or alcohol addiction.
• NYHA grade Ⅱ - Ⅳ heart failure, liver function significantly abnormal or kidney function significantly abnormal
• Pregnant women, women planning pregnancy or breastfeeding.
• Participated in other clinical trials within 3 months prior to the trial.
• Refuse to sign informed consent and agree to participate in this study.

Sponsors & Collaborators

• Yijie Ning: lead

Study Sites (1)

Full Spectrum Opening in Vivo Fluorescence Imaging System (DPM-IVFM-NIR-OF, Beijing Digital Precision Medicine Technology Co., Ltd., China)

Taiyuan, Shanxi, 030000, China

Location

Related Publications (1)

• van den Hoven P, Ooms S, van Manen L, van der Bogt KEA, van Schaik J, Hamming JF, Vahrmeijer AL, van der Vorst JR, Mieog JSD. A systematic review of the use of near-infrared fluorescence imaging in patients with peripheral artery disease. J Vasc Surg. 2019 Jul;70(1):286-297.e1. doi: 10.1016/j.jvs.2018.11.023.

  PMID: 31230648 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Diagnostic Imaging; Ultrasonography, Doppler, Duplex

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography, Doppler; Ultrasonography

Study Officials

• Ruijing Zhang, Doctoral degree

  Second Hospital of Shanxi Medical University

  STUDY DIRECTOR

• Honglin Dong, Doctoral degree

  Second Hospital of Shanxi Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of vascular surgery

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 22, 2024
• Study Start: September 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Starting 1 year after publication
• Access Criteria: If there are researchers who need to get the shared data, please contact Yijie Ning via email and explain the purpose of using the data. We will send the shared data to your email.

Locations

CN (1)