Peripheral Artery DiseaseNCT06917547
Study on PAD and CAS Based on Omics and Imaging
An observational study of Peripheral Artery Disease and Carotid Artery Stenosis, run by Yijie Ning.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Artery Disease, Carotid Artery Stenosis, Artery Stenosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Liuming Shi contact
About this study
Official title: Study on the Pathogenesis of PAD and CAS Based on Multi-omics Analysis and Multi-modal Imaging Technology
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.
Read the detailed description
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.
- Keywords
- Peripheral artery disease, Carotid Artery Stenosis, NIR-II Imaging, V-flow Imaging, Laser Speckle Imaging, Single-cell transcriptomics, Proteomics, Lipidomics, Metabolomics
- Medical subject headings
- Peripheral Arterial Disease, Carotid Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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).
Measured: Baseline, 6 months
Proteomics for CAS and PAD patients
Protein abundance will be measured in intensity units (AU) or nanograms per milliliter (ng/mL)
Measured: Baseline, 6 months
Lipidomics for CAS and PAD patients
Lipid species concentrations will be reported in micromoles per liter (µmol/L).
Measured: Baseline, 6 months
Metabolomics for CAS and PAD patients
Metabolite levels will be quantified in micromoles per liter (µmol/L).
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yijie Ning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yijie Ning, Second Hospital of Shanxi Medical University
- Investigators
- Honglin Dong, Principal investigator, Second Hospital of Shanxi Medical UniversityRuijing Zhang, Study director, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917547
- Sponsor's protocol ID
- [2025]YX024
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 39929338
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Pathogenesis of PAD and CAS Based on Multi-omics Analysis and Multi-modal Imaging Technology
- ClinicalTrials.gov ID
- NCT06917547
- Acronym / sponsor ID
- [2025]YX024
- Keywords
- Peripheral artery disease, Carotid Artery Stenosis, NIR-II Imaging, V-flow Imaging, Laser Speckle Imaging, Single-cell transcriptomics, Proteomics, Lipidomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yijie NingUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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".
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".
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".
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".
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.
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).
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)
Lipidomics for CAS and PAD patients
Time frame: Baseline, 6 months
Lipid species concentrations will be reported in micromoles per liter (µmol/L).
Metabolomics for CAS and PAD patients
Time frame: Baseline, 6 months
Metabolite levels will be quantified in micromoles per liter (µmol/L).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 39929338Ning 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Peripheral Artery Disease
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liuming Shi contact
Honglin Dong principal investigator
Second Hospital of Shanxi Medical University
Ruijing Zhang study director
Second Hospital of Shanxi Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease and Carotid Artery Stenosis, run by Yijie Ning.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yijie Ning (15735010056, N15735010056@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time related NIR-II parameters for CAS and PAD patients (time frame: Baseline, 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06917547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.