Study on PAD and CAS Based on Omics and Imaging
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorYijie Ning
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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".
Time frame
Baseline, 6 months2
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".
Time frame
Baseline, 6 months3
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".
Time frame
Baseline, 6 months4
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".
Time frame
Baseline, 6 monthsLocations
Sponsors and contacts
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Yijie Ning
Lead sponsor
Second Hospital of Shanxi Medical University
Sponsor institution
Source ClinicalTrials.gov
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