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/NCT05970926</url>
    </required_header>
    <id_info>
      <org_study_id>NOVAEA-HFUS-01</org_study_id>
      <nct_id>NCT05970926</nct_id>
    </id_info>
    <brief_title>Normal Reference Values in Han Adults of Extremity Arterial Structure and Hemodynamics by High-frequency Ultrasound</brief_title>
    <acronym>NOVAEA-HFUS</acronym>
    <official_title>Normal Reference Values in Han Adults of Extremity Arterial Structure and Hemodynamics by High-frequency Ultrasound: a Multi-center Study in China</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Hospital of China Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Hospital of China Medical University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        In recent years, high-frequency ultrasound, due to its higher resolution, can clearly display&#xD;
        the superficial vascular structure and blood flow, and can detect vascular lesions early,&#xD;
        providing a new non-invasive tool for clinical observation of the structure and blood flow of&#xD;
        the extremity artery. The purpose of this multi-center study is to establish the normal value&#xD;
        of high frequency ultrasound for the structure and blood flow of the extremity arteries of&#xD;
        Chinese Han adults, and to explore the influencing factors, so as to provide a quantitative&#xD;
        reference for the early diagnosis, degree evaluation and curative effect observation of the&#xD;
        structure and blood flow of the extremities.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The extremity artery is the peripheral blood vessel of the whole body, and it is often&#xD;
        involved early in the diseases that are easy to damage the small vessels, such as&#xD;
        atherosclerosis and connective tissue diseases. Early lower limb atherosclerosis mainly&#xD;
        occurs in the dorsal foot artery, which is commonly seen in people with diabetes and&#xD;
        long-term smoking. Connective tissue diseases such as systemic sclerosis and systemic lupus&#xD;
        erythematosus also mainly involve small blood vessels, and vascular lesions may appear&#xD;
        earlier than those of other specific organs such as heart and lung. Because of its shallow&#xD;
        location, the extremity artery can be better used as a screening site for vascular diseases,&#xD;
        and it is the window for early reaction of vascular diseases.However, the early stage of&#xD;
        extremity artery disease is easy to be ignored, and patients often have pain and numbness of&#xD;
        the affected limb. When the disease is severe, it can lead to ulcer not healing, and even&#xD;
        limb gangrene and amputation, which greatly affects the quality of life and brings huge&#xD;
        troubles and economic pressure to the patients. Therefore, early diagnosis of extremity&#xD;
        arterial lesions is of great significance for early diagnosis of microvascular injury&#xD;
        diseases such as atherosclerosis and connective tissue diseases, reducing the incidence of&#xD;
        complications, and reducing the rate of amputation and mortality.&#xD;
  &#xD;
        Ultrasound is a non-invasive imaging technique widely used in clinic. In recent years, with&#xD;
        the development of ultrasound technology, the frequency of ultrasonic probes has been&#xD;
        increasing. Because of its higher resolution, high-frequency ultrasound can clearly display&#xD;
        the superficial vascular structure and blood flow, detect vascular lesions early, and&#xD;
        accurately quantify the degree of stenosis, providing a new and beneficial tool for clinical&#xD;
        observation of the structure and blood flow of the extremity artery. The purpose of this&#xD;
        multi-center clinical study was to establish the normal value of high frequency ultrasound&#xD;
        for the structure and blood flow of the extremities of Chinese Han adults, and to explore its&#xD;
        influencing factors, so as to provide a quantitative reference for the early diagnosis,&#xD;
        degree evaluation and curative effect observation of the structure and blood flow of the&#xD;
        extremities.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Intima thickness of dorsalis pedis artery and proper palmar digital artery</measure>
      <time_frame>1 day</time_frame>
      <description>Intima thickness reflects the changes of vascular wall structure and is used for early evaluation of arterial disease.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood flow velocity of dorsalis pedis artery and proper palmar digital artery</measure>
      <time_frame>1 day</time_frame>
      <description>Blood flow velocity reflects hemodynamic changes and is used for early evaluation of arterial disease.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">540</enrollment>
    <condition>Healthy Volunteer</condition>
    <condition>Artery Disease</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>high-frequency ultrasound</intervention_name>
      <description>The volunteers will be given a high-frequency ultrasound examination of the extremity arteries, which is non-invasive, and the parameters of arterial structure and blood flow will be measured.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Chinese healthy Han adults&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Han nationality;&#xD;
  &#xD;
            2. Ages 18-79;&#xD;
  &#xD;
            3. Normal blood pressure (139-90/89-60mmHg);&#xD;
  &#xD;
            4. Body mass index &lt; 30 kg/m2;&#xD;
  &#xD;
            5. Blood routine, fasting blood glucose, blood lipid, liver and kidney function,&#xD;
               electrocardiogram were normal;&#xD;
  &#xD;
            6. No history of cyanosis of hands and feet, cold stimulation without discomfort, no&#xD;
               Raynaud phenomenon has occurred in all parts of the body;&#xD;
  &#xD;
            7. No cardiovascular disease, diabetes, rheumatic connective tissue disease, serious&#xD;
               liver and kidney dysfunction;&#xD;
  &#xD;
            8. No history of drug use affecting cardiovascular system.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with hypertension, diabetes, hyperthyroidism, arrhythmia and other diseases;&#xD;
  &#xD;
            2. Patients with systemic lupus erythematosus, polymyositis, rheumatoid arthritis and&#xD;
               other connective tissue diseases;&#xD;
  &#xD;
            3. A history of related blood diseases;&#xD;
  &#xD;
            4. Have taken vasoconstrictor drugs in the past 1 month;&#xD;
  &#xD;
            5. Gangrene of fingers and toes or history of trauma or surgery;&#xD;
  &#xD;
            6. Have a history of handicraft, hammering, digging and other related work;&#xD;
  &#xD;
            7. Have a long history of smoking and drinking;&#xD;
  &#xD;
            8. Peripheral vascular disease, arterial occlusion can not detect blood flow signal;&#xD;
  &#xD;
            9. Unable to cooperate with the examiner.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>79 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lixin Jiang, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai Jiao Tong University School of Medicine</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xinhua Ye, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>WeiDong Ren, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shengjing Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xin Guan, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tianjin Chest Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hongning Yin, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Second Hospital of Hebei Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xiaoshan Zhang, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Affiliated Hospital of Inner Mongolia Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yuhong Zhang, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Second Affiliated Hospital of Dalian Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Qingxiong Yue, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dalian Municipal Central Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chunyan Ma, PHD</last_name>
      <phone>13998816448</phone>
      <email>cmu1h_mcy@126.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>First Hospital of China Medical University</investigator_affiliation>
      <investigator_full_name>Chunyan Ma</investigator_full_name>
      <investigator_title>Chief of Cardiovascular Ultrasound</investigator_title>
    </responsible_party>
    <keyword>extremity arterial structure</keyword>
    <keyword>extremity arterial blood flow</keyword>
    <keyword>high-frequency ultrasound</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>May 28, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT05970926/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>May 28, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT05970926/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05970926
  org study id: NOVAEA-HFUS-01
  nct id: NCT05970926
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  In recent years, high-frequency ultrasound, due to its higher resolution, can clearly display
        the superficial vascular structure and blood flow, and can detect vascular lesions early,
        providing a new non-invasive tool for clinical observation of the structure and blood flow of
        the extremity artery. The purpose of this multi-center study is to establish the normal value
        of high frequency ultrasound for the structure and blood flow of the extremity arteries of
        Chinese Han adults, and to explore the influencing factors, so as to provide a quantitative
        reference for the early diagnosis, degree evaluation and curative effect observation of the
        structure and blood flow of the extremities.
  The extremity artery is the peripheral blood vessel of the whole body, and it is often
        involved early in the diseases that are easy to damage the small vessels, such as
        atherosclerosis and connective tissue diseases. Early lower limb atherosclerosis mainly
        occurs in the dorsal foot artery, which is commonly seen in people with diabetes and
        long-term smoking. Connective tissue diseases such as systemic sclerosis and systemic lupus
        erythematosus also mainly involve small blood vessels, and vascular lesions may appear
        earlier than those of other specific organs such as heart and lung. Because of its shallow
        location, the extremity artery can be better used as a screening site for vascular diseases,
        and it is the window for early reaction of vascular diseases.However, the early stage of
        extremity artery disease is easy to be ignored, and patients often have pain and numbness of
        the affected limb. When the disease is severe, it can lead to ulcer not healing, and even
        limb gangrene and amputation, which greatly affects the quality of life and brings huge
        troubles and economic pressure to the patients. Therefore, early diagnosis of extremity
        arterial lesions is of great significance for early diagnosis of microvascular injury
        diseases such as atherosclerosis and connective tissue diseases, reducing the incidence of
        complications, and reducing the rate of amputation and mortality.
  
        Ultrasound is a non-invasive imaging technique widely used in clinic. In recent years, with
        the development of ultrasound technology, the frequency of ultrasonic probes has been
        increasing. Because of its higher resolution, high-frequency ultrasound can clearly display
        the superficial vascular structure and blood flow, detect vascular lesions early, and
        accurately quantify the degree of stenosis, providing a new and beneficial tool for clinical
        observation of the structure and blood flow of the extremity artery. The purpose of this
        multi-center clinical study was to establish the normal value of high frequency ultrasound
        for the structure and blood flow of the extremities of Chinese Han adults, and to explore its
        influencing factors, so as to provide a quantitative reference for the early diagnosis,
        degree evaluation and curative effect observation of the structure and blood flow of the
        extremities.
  observational model: Cohort
  time perspective: Prospective
  measure: Intima thickness of dorsalis pedis artery and proper palmar digital artery
  time frame: 1 day
  description: Intima thickness reflects the changes of vascular wall structure and is used for early evaluation of arterial disease.
  measure: Blood flow velocity of dorsalis pedis artery and proper palmar digital artery
  time frame: 1 day
  description: Blood flow velocity reflects hemodynamic changes and is used for early evaluation of arterial disease.
  intervention type: Device
  intervention name: high-frequency ultrasound
  description: The volunteers will be given a high-frequency ultrasound examination of the extremity arteries, which is non-invasive, and the parameters of arterial structure and blood flow will be measured.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 18 Years
  maximum age: 79 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lixin Jiang, PHD
  role: Principal Investigator
  affiliation: Shanghai Jiao Tong University School of Medicine
  last name: Xinhua Ye, PHD
  role: Principal Investigator
  affiliation: The First Affiliated Hospital with Nanjing Medical University
  last name: WeiDong Ren, PHD
  role: Principal Investigator
  affiliation: Shengjing Hospital
  last name: Xin Guan, PHD
  role: Principal Investigator
  affiliation: Tianjin Chest Hospital
  last name: Hongning Yin, PHD
  role: Principal Investigator
  affiliation: The Second Hospital of Hebei Medical University
  last name: Xiaoshan Zhang, PHD
  role: Principal Investigator
  affiliation: The Affiliated Hospital of Inner Mongolia Medical University
  last name: Yuhong Zhang, PHD
  role: Principal Investigator
  affiliation: The Second Affiliated Hospital of Dalian Medical University
  last name: Qingxiong Yue, PHD
  role: Principal Investigator
  affiliation: Dalian Municipal Central Hospital
  last name: Chunyan Ma, PHD
  phone: 13998816448
  email: cmu1h_mcy@126.com
  responsible party type: Principal Investigator
  investigator affiliation: First Hospital of China Medical University
  investigator full name: Chunyan Ma
  investigator title: Chief of Cardiovascular Ultrasound
  sharing ipd: No
  provided document: 
  provided document: 