Study on PAD and CAS Based on Omics and Imaging

NCT06917547 | Not Yet Recruiting

• 1 other identifier: [2025]YX024
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to investigate the pathogenesis of Peripheral Artery Disease (PAD) and Carotid Artery Stenosis (CAS) using a comprehensive multi-omics and multi-modal imaging approach. The study will enroll patients diagnosed with PAD or CAS and perform advanced imaging techniques, including NIR-II Imaging, DUS-based V-flow Imaging, and Laser Speckle Imaging, to assess vascular structure and function. Simultaneously, single-cell transcriptomics, metabolomics, lipidomics, and proteomics analyses will be conducted on patient samples to identify key molecular targets and pathways involved in disease progression. Machine learning algorithms will be employed to integrate imaging and multi-omics data, enabling the development of predictive models for more accurate disease diagnosis and stratification. The findings from this study are expected to provide novel insights into the molecular mechanisms underlying PAD and CAS and contribute to the development of personalized therapeutic strategies.

Conditions

Peripheral Artery Disease; Carotid Artery Stenosis; Artery Stenosis

Keywords

Peripheral artery disease; Carotid Artery Stenosis; NIR-II Imaging; V-flow Imaging; Laser Speckle Imaging; Single-cell transcriptomics; Proteomics; Lipidomics; Metabolomics

Outcome Measures

Primary Outcomes (9)

• Time related NIR-II parameters for CAS and PAD patients

  In this study, 5-minute NIR-II imaging video of each patient was processed into time-intensity curves to quantify the imaging results. Three time related parameters on time-intensity curves were extracted, including：T start (s), Tmax (s), T 1/2 (s). Note: "s" is used as the unit "second".

  Baseline, 6 months

• Intensity related NIR-II parameters for CAS and PAD patients

  In this study, 5-minute NIR-II imaging video of each patient was processed into time-intensity curves to quantify the imaging results. The intensity related parameters on time-intensity curves were extracted as Imax (Fi). Note: "Fi" is used as the unit "fluorescence intensity".

  Baseline, 6 months

• Time-intensity related NIR-II parameters for CAS and PAD patients

  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

• Assessment of Wall Shear Stress (WSS) Using V-flow Imaging

  V-flow imaging will be used to measure WSS in the carotid and peripheral arteries of patients with PAD and CAS. WSS (Pa), a critical hemodynamic parameter, will be calculated based on blood flow velocity and vessel geometry. This metric will help evaluate endothelial function and vascular remodeling associated with disease progression. Note: "Pa" is used as the unit "Pascal".

  Baseline, 6 months

• Assessment of Microvascular Perfusion in the Dorsum of the Foot Using Laser Speckle Imaging in Patients with PAD and CAS

  Laser speckle imaging (LSI) will be used to evaluate microvascular perfusion in the dorsum of the foot in patients with Peripheral Artery Disease (PAD). This non-invasive imaging technique will quantify blood flow dynamics in the microcirculation by analyzing the speckle contrast generated by laser illumination. The perfusion metrics, including fluorescence intensity (FI), will be derived from LSI to assess microvascular function. These measurements will provide insights into peripheral microvascular perfusion deficits and their correlation with disease severity, helping to identify functional impairments and evaluate therapeutic outcomes.

  Baseline, 6 months

• Single-cell Transcriptomics for CAS and PAD patients

  Gene expression levels will be quantified as transcripts per million (TPM) or reads per kilobase per million (RPKM).

  Baseline, 6 months

• Proteomics for CAS and PAD patients

  Protein abundance will be measured in intensity units (AU) or nanograms per milliliter (ng/mL)

  Baseline, 6 months

• Lipidomics for CAS and PAD patients

  Lipid species concentrations will be reported in micromoles per liter (µmol/L).

  Baseline, 6 months

• Metabolomics for CAS and PAD patients

  Metabolite levels will be quantified in micromoles per liter (µmol/L).

  Baseline, 6 months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of patients diagnosed with Peripheral Artery Disease (PAD) or Carotid Artery Stenosis (CAS) who are admitted to the Department of Vascular Surgery at the Second Hospital of Shanxi Medical University. Eligible participants will be males or females aged between 18 and 85 years. Patients must be conscious, fully informed about the study, and willing to provide written informed consent. The study aims to enroll a diverse cohort to ensure representative findings. Exclusion criteria include non-atherosclerotic stenosis, prior interventional or surgical treatments for PAD, significant cardiac, hepatic, or renal dysfunction, acute infections, and other conditions that may confound the study results. Pregnant or breastfeeding women and individuals who have participated in other clinical trials within the past 3 months will also be excluded.

You may qualify if:

• The study subjects are inpatients from the Department of Vascular Surgery at the Second Hospital of Shanxi Medical University.
• Males or females aged between 18 and 85 years.
• Diagnosed with Peripheral Artery Disease (PAD) or Carotid Artery Stenosis (CAS).
• Participants are conscious, fully informed about the study content, and have signed the informed consent form, agreeing to participate in this study.

You may not qualify if:

• Non-atherosclerotic stenosis (e.g., vasculitis or dissection).
• PAD patients who have previously undergone interventional treatments (e.g., balloon angioplasty or stent placement) and/or surgical procedures.
• Patients with heart failure classified as NYHA Class II-IV or those with a history of coronary artery disease.
• Patients with acute infections, tumors, severe arrhythmias, psychiatric disorders, or drug/alcohol addiction.
• Significant liver dysfunction or a history of liver diseases, including: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding twice the upper limit of normal. History of cirrhosis, hepatic encephalopathy, esophageal varices, or portosystemic shunt.
• Significant renal dysfunction or a history of kidney diseases, including: Serum creatinine levels exceeding 1.5 times the upper limit of normal. History of dialysis or nephrotic syndrome.
• Pregnant women, those planning to become pregnant, or breastfeeding women.
• Participation in other clinical trials within the past 3 months.
• Refusal to sign the informed consent form or participate in this study.

Sponsors & Collaborators

• Yijie Ning: lead

Related Publications (1)

• Ning Y, Hu J, Zhu Y, Tang W, Yan S, Li H, Zhang Z, Lu C, Ren K, Shi P, Yao T, Wang Q, Zhao Y, Gao T, Zhang R, Dong H. NIR-II imaging-based detection of early changes in lower limb perfusion in type 2 diabetes patients without peripheral artery disease. Diabetes Res Clin Pract. 2025 Mar;221:112038. doi: 10.1016/j.diabres.2025.112038. Epub 2025 Feb 8.

  PMID: 39929338 BACKGROUND

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood (20-30 mL) will be collected from patients with PAD and CAS. Density gradient centrifugation will be used to isolate PBMCs for single-cell transcriptomics to analyze cell type-specific gene expression. Serum will be separated for proteomics, lipidomics, and metabolomics analyses to identify disease biomarkers and molecular pathways. PBMCs will be cryopreserved, and serum aliquots will be stored at -80°C. Sample quality will be ensured through cell viability assessment and visual inspection for hemolysis.

MeSH Terms

Conditions

Peripheral Arterial Disease; Carotid Stenosis

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Honglin Dong

  Second Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

• Ruijing Zhang

  Second Hospital of Shanxi Medical University

  STUDY DIRECTOR

Central Study Contacts

Yijie Ning

CONTACT

15735010056; N15735010056@163.com

Liuming Shi

CONTACT

shiliuming228@163.com

Study Design

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

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 8, 2025
• Study Start: April 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 8, 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.