<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/NCT02241239</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0901-1</org_study_id>
    <nct_id>NCT02241239</nct_id>
  </id_info>
  <brief_title>A Comparison of the Estimates of Fuwai and Reynolds Risk Model</brief_title>
  <official_title>A Comparison of the Estimates of Fuwai and Reynolds Risk Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan Asia Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan Asia Heart Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are many risk prediction models. And their estimates are different. This study aimed to&#xD;
      investigate the differences between the estimates of Fuwai and Reynolds risk model in&#xD;
      Chinese, and investigate the reason for the differences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants will examined for cardiovascular risk factors, and their cardiovascular&#xD;
      risks will be calculated based on the values of the risk factors using cardiovascular risk&#xD;
      models. The estimates of different risk models will be compared, and the levels of&#xD;
      traditional risk factors will be adjusted in order to evaluate the impacts of uncommon risk&#xD;
      factors such as social and genetic risk factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>cardiovascular risk</measure>
    <time_frame>1 day</time_frame>
    <description>The cardiovascular risk is the probability of the occurrence of coronary heart disease and stroke. The cardiovascular risk is calculated by risk prediction models based on the patient's risk factors.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Coronary Heart Disease and Stroke</condition>
  <arm_group>
    <arm_group_label>participants</arm_group_label>
    <description>healthy adults without stroke and coronary heart disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        adults without coronary heart disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: adults -&#xD;
&#xD;
        Exclusion Criteria: with coronary heart disease&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Youping Chen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wuhan Asia Heart Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Youping Chen, M.D,</last_name>
    <phone>+86-27-65796888</phone>
    <phone_ext>8501</phone_ext>
    <email>sageeeee@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wuhan Asia Heart Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Youping Chen, MD</last_name>
      <phone>+86-27-65796888</phone>
      <email>sageeeee@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wuhan Asia Heart Hospital</name>
      <address>
        <city>Wuhan</city>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Youping Chen, M.D.</last_name>
      <phone>+86-27-65796888</phone>
      <phone_ext>8501</phone_ext>
      <email>sageeeee@163.com</email>
    </contact>
    <investigator>
      <last_name>Youping Chen, M.D,</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>November 5, 2014</last_update_submitted>
  <last_update_submitted_qc>November 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02241239
org study id: 2014-0901-1
nct id: NCT02241239
lead sponsor: 
has dmc: Yes
There are many risk prediction models. And their estimates are different. This study aimed to
      investigate the differences between the estimates of Fuwai and Reynolds risk model in
      Chinese, and investigate the reason for the differences.
The participants will examined for cardiovascular risk factors, and their cardiovascular
      risks will be calculated based on the values of the risk factors using cardiovascular risk
      models. The estimates of different risk models will be compared, and the levels of
      traditional risk factors will be adjusted in order to evaluate the impacts of uncommon risk
      factors such as social and genetic risk factors.
observational model: Cohort
time perspective: Prospective
measure: cardiovascular risk
time frame: 1 day
description: The cardiovascular risk is the probability of the occurrence of coronary heart disease and stroke. The cardiovascular risk is calculated by risk prediction models based on the patient's risk factors.
arm group label: participants
description: healthy adults without stroke and coronary heart disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Youping Chen, M.D.
role: Principal Investigator
affiliation: Wuhan Asia Heart Hospital
last name: Youping Chen, M.D,
phone: +86-27-65796888
phone ext: 8501
email: sageeeee@163.com
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia