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NCT Number: NCT06917547

Study on PAD and CAS Based on Omics and Imaging

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

Background and Rationale Peripheral Artery Disease (PAD) and Carotid Artery Stenosis (CAS) are prevalent vascular disorders associated with significant morbidity and mortality. Despite advances in diagnostic and therapeutic approaches, the molecular mechanisms driving these diseases remain poorly understood. This study leverages cutting-edge multi-omics technologies and advanced imaging modalities to unravel the complex pathogenesis of PAD and CAS, with the ultimate goal of identifying novel biomarkers and therapeutic targets.

Study Objectives Primary Objective: To integrate multi-modal imaging data (NIR-II Imaging, DUS-based V-flow Imaging, and Laser Speckle Imaging) with multi-omics data using machine learning algorithms for improved disease prediction and stratification.

Study Design

This is a prospective, observational study involving patients diagnosed with PAD or CAS. The study will include the following components:

Imaging Analysis:

  • NIR-II Imaging: To visualize deep tissue vascular structures and hemodynamics.
  • DUS-based V-flow Imaging: To assess blood flow dynamics and vascular stenosis.
  • Laser Speckle Imaging: To evaluate microvascular perfusion and endothelial function.

Multi-Omics Analysis:

  • Single-cell Transcriptomics: To profile gene expression at the single-cell level and identify cell-type-specific changes.
  • Metabolomics and Lipidomics: To characterize metabolic and lipid profiles associated with disease progression.
  • Proteomics: To identify differentially expressed proteins and signaling pathways.
  • Data Integration and Machine Learning:

Imaging and multi-omics data will be integrated using advanced machine learning algorithms to develop predictive models for disease diagnosis, progression, and therapeutic response.

Study Population The study will enroll patients diagnosed with PAD or CAS, along with age- and sex-matched healthy controls. Inclusion and exclusion criteria will be applied to ensure a homogeneous study population.

Expected Outcomes

  • Identification of key molecular and cellular pathways involved in PAD and CAS pathogenesis.
  • Development of a multi-modal predictive model for accurate disease diagnosis and stratification.
  • Discovery of novel biomarkers and therapeutic targets for personalized medicine.

Ethical Considerations The study protocol has been reviewed and approved by the Institutional Review Board (IRB) to ensure the protection of human subjects. Informed consent will be obtained from all participants prior to their enrollment in the study.

Significance This study represents a pioneering effort to integrate multi-omics and multi-modal imaging data for a comprehensive understanding of PAD and CAS. The findings are expected to advance the field of vascular biology and contribute to the development of precision medicine approaches for these debilitating diseases.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Time related NIR-II parameters for CAS and PAD patients

    Time frame: Baseline, 6 months

    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".

  2. Intensity related NIR-II parameters for CAS and PAD patients

    Time frame: Baseline, 6 months

    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".

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

    Time frame: Baseline, 6 months

    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".

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

    Time frame: Baseline, 6 months

    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".

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

    Time frame: Baseline, 6 months

    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.

  6. Single-cell Transcriptomics for CAS and PAD patients

    Time frame: Baseline, 6 months

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

  7. Proteomics for CAS and PAD patients

    Time frame: Baseline, 6 months

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

  8. Lipidomics for CAS and PAD patients

    Time frame: Baseline, 6 months

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

  9. Metabolomics for CAS and PAD patients

    Time frame: Baseline, 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Liuming Shi

CONTACT

[email protected]

Yijie Ning

CONTACT

[email protected]

15735010056

Sponsors and collaborators

Lead sponsor

Yijie Ning

Other

Registry information

Official study title

Study on the Pathogenesis of PAD and CAS Based on Multi-omics Analysis and Multi-modal Imaging Technology

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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