<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/NCT03785626</url>
  </required_header>
  <id_info>
    <org_study_id>VUS-CEA</org_study_id>
    <nct_id>NCT03785626</nct_id>
  </id_info>
  <brief_title>Risk Prediction of Carotid Endarterectomy by Vascular Ultrasound Evaluation</brief_title>
  <official_title>Quantitative Prediction of Carotid Endarterectomy Risk Based on Vascular Structure and Hemodynamics by Vascular Ultrasound Evaluation System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuanwu Hospital, Beijing</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>
      Carotid endarterectomy (CEA) is one of the surgical treatment methods for the reconstruction&#xD;
      of arterial stenosis or occlusion. Perioperative stroke, cerebral hemorrhage,hyperperfusion&#xD;
      syndrome and death are main complications of CEA. Investigator have established a risk&#xD;
      prediction model of the procedure based on vascular characteristics and hemodynamic&#xD;
      parameters retrospectively. This prospective study was aimed to verify the predictive ability&#xD;
      of CEA comprehensive prediction model through the analysis of patients receiving CEA&#xD;
      procedure in the investigator's center in the next two years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects: In this study, a total of 600-800 patients with severe carotid artery stenosis or&#xD;
      occlusion who scheduled for CEA are recruited.&#xD;
&#xD;
      Data collection:&#xD;
&#xD;
        1. The plaque characteristics, stenosis degrees of carotid artery and intracranial&#xD;
           arteries, and collateral circulation are evaluated by ultrasound prior to the procedure.&#xD;
&#xD;
        2. CT, MRI and digital subtraction angiography (DSA) were applied pre- and post-procedure&#xD;
           to identify the clinical events.&#xD;
&#xD;
      Endpoint: The combination endpoints events of death, cerebral hemorrhage , newly cerebral&#xD;
      infarction, hyperperfusion syndrome within 30-day after the procedure.&#xD;
&#xD;
      Statistical analysis plans: The Statistical Package of Social Sciences (SPSS version 22.0)&#xD;
      software are used for statistical analysis. The area under the receiver operating&#xD;
      characteristic (ROC) curve and hosmer-lemeshow test were used to evaluate the discrimination&#xD;
      and calibration of the risk prediction model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>The rate of death, stroke or hemorrhage</measure>
    <time_frame>30 days postoperation</time_frame>
    <description>The rate of combination endpoints events of death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome.</description>
  </primary_outcome>
  <enrollment type="Actual">1498</enrollment>
  <condition>Stroke</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CEA surgery</intervention_name>
    <description>patients with carotid artery severe (70-99%) stenosis or occlusion received CEA surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with carotid artery severe (70-99%) stenosis or occlusion who are scheduled for&#xD;
        CEA.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with carotid artery severe (70-99%) stenosis or occlusion diagnosed by color&#xD;
             duplex flow imaging (CDFI) and confirmed by CT angiography (CTA) or digital&#xD;
             subtraction angiography (DSA).&#xD;
&#xD;
          2. Patient has the indications for carotid artery stenting or CEA according to the&#xD;
             guidelines published by the Stroke Prevention Engineering Committee, the National&#xD;
             Health Commission of China.&#xD;
&#xD;
          3. MRI and CT were applicated pre- and postoperation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with non-atherosclerotic carotid artery stenosis or occlusion, such as&#xD;
             dissection, aneurysm, arteritis, cardiac embolism, et al.&#xD;
&#xD;
          2. Lack of any imaging evaluation results, such as ultrasound, MRI or CT.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Xuanwu Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>July 14, 2022</last_update_submitted>
  <last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ultrasound</keyword>
  <keyword>Carotid Endarterectomy</keyword>
  <keyword>Risk Prediction Model</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03785626
org study id: VUS-CEA
nct id: NCT03785626
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Carotid endarterectomy (CEA) is one of the surgical treatment methods for the reconstruction
      of arterial stenosis or occlusion. Perioperative stroke, cerebral hemorrhage,hyperperfusion
      syndrome and death are main complications of CEA. Investigator have established a risk
      prediction model of the procedure based on vascular characteristics and hemodynamic
      parameters retrospectively. This prospective study was aimed to verify the predictive ability
      of CEA comprehensive prediction model through the analysis of patients receiving CEA
      procedure in the investigator's center in the next two years.
Subjects: In this study, a total of 600-800 patients with severe carotid artery stenosis or
      occlusion who scheduled for CEA are recruited.

      Data collection:

        1. The plaque characteristics, stenosis degrees of carotid artery and intracranial
           arteries, and collateral circulation are evaluated by ultrasound prior to the procedure.

        2. CT, MRI and digital subtraction angiography (DSA) were applied pre- and post-procedure
           to identify the clinical events.

      Endpoint: The combination endpoints events of death, cerebral hemorrhage , newly cerebral
      infarction, hyperperfusion syndrome within 30-day after the procedure.

      Statistical analysis plans: The Statistical Package of Social Sciences (SPSS version 22.0)
      software are used for statistical analysis. The area under the receiver operating
      characteristic (ROC) curve and hosmer-lemeshow test were used to evaluate the discrimination
      and calibration of the risk prediction model.
observational model: Cohort
time perspective: Prospective
measure: The rate of death, stroke or hemorrhage
time frame: 30 days postoperation
description: The rate of combination endpoints events of death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome.
intervention type: Procedure
intervention name: CEA surgery
description: patients with carotid artery severe (70-99%) stenosis or occlusion received CEA surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No