<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/NCT01732952</url>
  </required_header>
  <id_info>
    <org_study_id>0000-271-0</org_study_id>
    <nct_id>NCT01732952</nct_id>
  </id_info>
  <brief_title>Dyslipidemia International Survey-China</brief_title>
  <acronym>DYSIS-China</acronym>
  <official_title>Dyslipidemia International Survey - China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Society of Cardiology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Society of Cardiology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This cross-sectional, non-interventional, and observational study will assess the lipid&#xD;
      profile of patients who have been taking lipid-modifying drugs (i.e., proportion of patients&#xD;
      achieving treatment to goal according to national and international lipid management&#xD;
      guidelines) during a single visit to their physicians on an outpatient basis in 6&#xD;
      representative geo-economic regions in China: Northeast, North, East, South, Southwest, and&#xD;
      Northwest; and within each region, in three tiers of hospitals: tier 3 (primary or teaching&#xD;
      hospitals), tier 2 (secondary or city level hospitals), and tier 1 (community&#xD;
      hospitals/health centers). The investigators will primarily be cardiologists,&#xD;
      endocrinologists, neurologists, gerontologists, internists, or other physicians who are&#xD;
      representative of the general population of physicians managing patients with dyslipidemia&#xD;
      and/or at high risk for cardiovascular events likely to be treated with lipid-modifying&#xD;
      drugs. Demographic data, cardiovascular risk factors, a history of cardiovascular disease and&#xD;
      cardiovascular treatments will be documented in a single visit through patient clinical&#xD;
      examination and chart review.&#xD;
&#xD;
      DYSIS-China is part of a string of epidemiological studies that share the same master&#xD;
      protocol, which has been conducted in different countries mainly in Europe and Canada. The&#xD;
      analysis of the pooled studies including overall data and cross-country comparisons is the&#xD;
      subject of a distinct protocol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the prevalence and types of persistent lipid abnormalities in patients aged &gt; 45 years treated with a lipid-modifying drug</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>assess patient characteristics, including CV risk levels, in the subsets of patients with persistent lipid abnormalities</measure>
    <time_frame>6months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>explore a potential relationship between the persistence of lipid abnormalities and the local known (historical) prevalence of CV morbidity/mortality</measure>
    <time_frame>6months</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">25000</enrollment>
  <condition>the Prevalence,Lipid Abnormalities,</condition>
  <arm_group>
    <arm_group_label>regions,hospitals,age, gender, risk levels, comorbidity,</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        1. Patient is an outpatient &gt; 45 years of age&#xD;
&#xD;
          2. Patient is currently* treated with a statin&#xD;
&#xD;
          3. Patient has a documented fasting lipid profile (&gt; 1 lipid parameter within the last 12&#xD;
             months) performed while on lipid-modifying therapy for at least 3 months&#xD;
&#xD;
          4. Patient agrees to participate in the study by giving informed consent.&#xD;
&#xD;
               -  Patient is already being treated with a lipid-modifying drug just before the&#xD;
                  visit. Patient for whom a lipid-modifying therapy is initiated at the time of the&#xD;
                  visit must not be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is an outpatient &gt; 45 years of age&#xD;
&#xD;
          2. Patient is currently* treated with a statin&#xD;
&#xD;
          3. Patient has a documented fasting lipid profile (&gt; 1 lipid parameter within the last 12&#xD;
             months) performed while on lipid-modifying therapy for at least 3 months&#xD;
&#xD;
          4. Patient agrees to participate in the study by giving informed consent.&#xD;
&#xD;
               -  Patient is already being treated with a lipid-modifying drug just before the&#xD;
                  visit. Patient for whom a lipid-modifying therapy is initiated at the time of the&#xD;
                  visit must not be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Patient is currently participating in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hu da yi, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese Society of Cardiology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hu da yi, Dr.</last_name>
    <phone>8601088324876</phone>
    <email>dayi.hu@medmail.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peiking University People' Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ding Rong Jing, Dr.</last_name>
      <phone>0108688325940</phone>
      <email>drj2003@sina.com</email>
    </contact>
    <investigator>
      <last_name>Ding rong jing, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>November 23, 2012</last_update_submitted>
  <last_update_submitted_qc>November 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Society of Cardiology</investigator_affiliation>
    <investigator_full_name>Hu Dayi</investigator_full_name>
    <investigator_title>Chinese Society of Cardiology</investigator_title>
  </responsible_party>
  <keyword>the prevalence,lipid abnormalities,CV risks</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
    <mesh_term>Dyslipidemias</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/NCT01732952
org study id: 0000-271-0
nct id: NCT01732952
lead sponsor: 
has dmc: Yes
This cross-sectional, non-interventional, and observational study will assess the lipid
      profile of patients who have been taking lipid-modifying drugs (i.e., proportion of patients
      achieving treatment to goal according to national and international lipid management
      guidelines) during a single visit to their physicians on an outpatient basis in 6
      representative geo-economic regions in China: Northeast, North, East, South, Southwest, and
      Northwest; and within each region, in three tiers of hospitals: tier 3 (primary or teaching
      hospitals), tier 2 (secondary or city level hospitals), and tier 1 (community
      hospitals/health centers). The investigators will primarily be cardiologists,
      endocrinologists, neurologists, gerontologists, internists, or other physicians who are
      representative of the general population of physicians managing patients with dyslipidemia
      and/or at high risk for cardiovascular events likely to be treated with lipid-modifying
      drugs. Demographic data, cardiovascular risk factors, a history of cardiovascular disease and
      cardiovascular treatments will be documented in a single visit through patient clinical
      examination and chart review.

      DYSIS-China is part of a string of epidemiological studies that share the same master
      protocol, which has been conducted in different countries mainly in Europe and Canada. The
      analysis of the pooled studies including overall data and cross-country comparisons is the
      subject of a distinct protocol.
observational model: Case-Only
time perspective: Cross-Sectional
measure: the prevalence and types of persistent lipid abnormalities in patients aged > 45 years treated with a lipid-modifying drug
time frame: 6 months
measure: assess patient characteristics, including CV risk levels, in the subsets of patients with persistent lipid abnormalities
time frame: 6months
measure: explore a potential relationship between the persistence of lipid abnormalities and the local known (historical) prevalence of CV morbidity/mortality
time frame: 6months
arm group label: regions,hospitals,age, gender, risk levels, comorbidity,
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Hu da yi, Dr.
role: Principal Investigator
affiliation: Chinese Society of Cardiology
last name: Hu da yi, Dr.
phone: 8601088324876
email: dayi.hu@medmail.com.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese Society of Cardiology
investigator full name: Hu Dayi
investigator title: Chinese Society of Cardiology
mesh term: Congenital Abnormalities
mesh term: Dyslipidemias