Study on the Pathogenesis of PAD and CAS Based on Multi-omics Analysis and Multi-modal Imaging Technology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Lipidomics for CAS and PAD patients
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Lipidomics for CAS and PAD patients
时间窗: Baseline, 6 months
Lipid species concentrations will be reported in micromoles per liter (µmol/L).
Metabolomics for CAS and PAD patients
时间窗: Baseline, 6 months
Metabolite levels will be quantified in micromoles per liter (µmol/L).
Time related NIR-II parameters for CAS and PAD patients
时间窗: 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".
Intensity related NIR-II parameters for CAS and PAD patients
时间窗: 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".
Assessment of Wall Shear Stress (WSS) Using V-flow Imaging
时间窗: 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".
Assessment of Microvascular Perfusion in the Dorsum of the Foot Using Laser Speckle Imaging in Patients with PAD and CAS
时间窗: 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.
Single-cell Transcriptomics for CAS and PAD patients
时间窗: Baseline, 6 months
Gene expression levels will be quantified as transcripts per million (TPM) or reads per kilobase per million (RPKM).
Proteomics for CAS and PAD patients
时间窗: Baseline, 6 months
Protein abundance will be measured in intensity units (AU) or nanograms per milliliter (ng/mL)
Time-intensity related NIR-II parameters for CAS and PAD patients
时间窗: 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".
次要结局
未报告次要终点
研究者
Yijie Ning
Doctor of vascular surgery
Second Hospital of Shanxi Medical University