xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06016608</url>
    </required_header>
    <id_info>
      <org_study_id>ChiCTR2300074638</org_study_id>
      <nct_id>NCT06016608</nct_id>
    </id_info>
    <brief_title>An Imaging Study of Polyvascular Disease</brief_title>
    <official_title>Early Screen, Systematic Evaluation and Risk Warning of Polyvascular Disease Based on Multi-modality Imaging</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Harbin Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Harbin Medical University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        1. Establish a multimodality imaging database for PVD, improve the one-stop screening&#xD;
             process for early PVD based on artificial intelligence, build a full-cycle control&#xD;
             information platform, and promote the construction and standardization of a&#xD;
             multidisciplinary co-morbidity and co-management diagnosis and treatment model.&#xD;
  &#xD;
          2. Based on non-invasive, zero-contrast ocular OCTA combined with one-stop CTA imaging of&#xD;
             the heart and brain, construct an integrated &quot;eye-heart-brain&quot; early warning model for&#xD;
             PVD, and explore a potential non-invasive and convenient early warning system for PVD.&#xD;
  &#xD;
          3. Based on the multi-omics, investigate EVs-mediated intercellular communication network,&#xD;
             elucidate the roles and regulatory mechanisms of EVs in the development of PVD, search&#xD;
             for potential targets for intervention, and construct an artificial intelligence-based&#xD;
             &quot;pan-vascular score&quot; risk assessment system based on the combination of multi-modality&#xD;
             imaging and multi-omics biomarkers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Task1: MACE</measure>
      <time_frame>1 year</time_frame>
      <description>All cause death, stroke, myocardial reinfarction, unplanned revascularization, lower extremity artery disease</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Task2: Plaque characteristics</measure>
      <time_frame>1 year</time_frame>
      <description>Plaque morphology on OCT</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1100</enrollment>
    <condition>Polyvascular Disease</condition>
    <arm_group>
      <arm_group_label>Polyvascular disease</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Magnetic Resonance Angiography, Ocular OCTA, CT Angiography</intervention_name>
      <description>Magnetic Resonance Angiography of intracranial artery, carotid artery, renal artery and lower extremity artery, CT angiography of coronary artery or intracranial artery</description>
      <arm_group_label>Polyvascular disease</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with polyvascular disease in the 2nd Affiliated Hospital of Harbin Medical&#xD;
          University&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Task 1:&#xD;
  &#xD;
            1. Patients with coronary artery disease (≥50% stenosis in any coronary artery on&#xD;
               coronary angiography)&#xD;
  &#xD;
            2. Age ≥18 years old&#xD;
  &#xD;
            3. Proposed OCT-IVUS integrated imaging system&#xD;
  &#xD;
            4. able to provide written informed consent prior to the start of any procedures related&#xD;
               to the study.&#xD;
  &#xD;
          Task 2:&#xD;
  &#xD;
            1. patients with coronary artery disease (coronary angiography reveals ≥50% degree of&#xD;
               stenosis in any coronary artery) and patients with stroke or TIA (confirmed by a&#xD;
               neurologist)&#xD;
  &#xD;
            2. Age ≥ 18 years&#xD;
  &#xD;
            3. able to provide written informed consent prior to the start of any procedures related&#xD;
               to the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Task 1:&#xD;
  &#xD;
            1. severely tortuous/calcified coronary arteries with anticipated difficulty in&#xD;
               completing the OCT-IVUS integrated imaging system&#xD;
  &#xD;
            2. uncontrolled congestive heart failure or acute left heart failure;plan&#xD;
  &#xD;
            3. claustrophobia;&#xD;
  &#xD;
            4. left main stem occlusion;&#xD;
  &#xD;
            5. proposed coronary artery bypass grafting (CABG);&#xD;
  &#xD;
            6. uncontrolled severe ventricular arrhythmia;&#xD;
  &#xD;
            7. active bleeding or severe bleeding tendency;&#xD;
  &#xD;
            8. acute stroke;&#xD;
  &#xD;
            9. patients with hemodynamic instability or unstable cardiac electrical activity&#xD;
               (including shock) ;&#xD;
  &#xD;
           10. severe renal insufficiency and/or anuria, except in cases where dialysis treatment has&#xD;
               been planned;&#xD;
  &#xD;
           11. contraindications to the application of contrast media;&#xD;
  &#xD;
           12. patients who are severely uncooperative due to psychiatric or serious systemic&#xD;
               illness;&#xD;
  &#xD;
           13. Patients who, in the opinion of the investigator, are unsuitable for participation in&#xD;
               the study.&#xD;
  &#xD;
          Task 2:&#xD;
  &#xD;
            1. patients who are unable to comply with the follow-up schedule;&#xD;
  &#xD;
            2. uncontrolled congestive heart failure or acute left heart failure;&#xD;
  &#xD;
            3. patients with a life expectancy of less than 6 months;&#xD;
  &#xD;
            4. left main stem occlusion;&#xD;
  &#xD;
            5. proposed coronary artery bypass grafting (CABG);&#xD;
  &#xD;
            6. uncontrolled severe ventricular arrhythmia;&#xD;
  &#xD;
            7. active bleeding or severe bleeding tendency;&#xD;
  &#xD;
            8. patients with hemodynamic instability or unstable cardiac electrical activity&#xD;
               (including shock) ;&#xD;
  &#xD;
            9. severe renal insufficiency and/or anuria, except in cases where dialysis treatment has&#xD;
               been planned;&#xD;
  &#xD;
           10. contraindications to the application of contrast media;&#xD;
  &#xD;
           11. patients who are severely uncooperative due to psychiatric or serious systemic&#xD;
               illness;&#xD;
  &#xD;
           12. patients who, in the opinion of the investigator, are not suitable for participation&#xD;
               in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Haibo Jia, MD. Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Second Affiliated Hospital of Harbin Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Minghao Liu, MD.</last_name>
      <phone>+8613764166251</phone>
      <email>baiyuedao@alumni.sjtu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Harbin Medical University</name>
        <address>
          <city>Harbin</city>
          <state>Heilongjiang</state>
          <zip>150000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Minghao Liu, MD.</last_name>
        <phone>+8613764166251</phone>
        <email>baiyuedao@alumni.sjtu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Harbin Medical University</investigator_affiliation>
      <investigator_full_name>Yu Bo</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06016608
  org study id: ChiCTR2300074638
  nct id: NCT06016608
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  1. Establish a multimodality imaging database for PVD, improve the one-stop screening
             process for early PVD based on artificial intelligence, build a full-cycle control
             information platform, and promote the construction and standardization of a
             multidisciplinary co-morbidity and co-management diagnosis and treatment model.
  
          2. Based on non-invasive, zero-contrast ocular OCTA combined with one-stop CTA imaging of
             the heart and brain, construct an integrated "eye-heart-brain" early warning model for
             PVD, and explore a potential non-invasive and convenient early warning system for PVD.
  
          3. Based on the multi-omics, investigate EVs-mediated intercellular communication network,
             elucidate the roles and regulatory mechanisms of EVs in the development of PVD, search
             for potential targets for intervention, and construct an artificial intelligence-based
             "pan-vascular score" risk assessment system based on the combination of multi-modality
             imaging and multi-omics biomarkers.
  observational model: Cohort
  time perspective: Prospective
  measure: Task1: MACE
  time frame: 1 year
  description: All cause death, stroke, myocardial reinfarction, unplanned revascularization, lower extremity artery disease
  measure: Task2: Plaque characteristics
  time frame: 1 year
  description: Plaque morphology on OCT
  arm group label: Polyvascular disease
  intervention type: Diagnostic Test
  intervention name: Magnetic Resonance Angiography, Ocular OCTA, CT Angiography
  description: Magnetic Resonance Angiography of intracranial artery, carotid artery, renal artery and lower extremity artery, CT angiography of coronary artery or intracranial artery
  arm group label: Polyvascular disease
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Haibo Jia, MD. Ph.D
  role: Principal Investigator
  affiliation: The Second Affiliated Hospital of Harbin Medical University
  last name: Minghao Liu, MD.
  phone: +8613764166251
  email: baiyuedao@alumni.sjtu.edu.cn
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Harbin Medical University
  investigator full name: Yu Bo
  investigator title: Director
  sharing ipd: No