<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/NCT01670396</url>
  </required_header>
  <id_info>
    <org_study_id>ZS-XN-ISR</org_study_id>
    <nct_id>NCT01670396</nct_id>
  </id_info>
  <brief_title>Genetics Study of In-stent Restenosis</brief_title>
  <acronym>ISR</acronym>
  <official_title>G Protein β3 Subunit (GNB3) Polymorphism and Restenosis of Coronary Drug-eluting Stents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesized that genetic variants of G protein influence the development&#xD;
      of restenosis and clinical outcome of patients receiving drug-eluting stents (DES).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although drug-eluting stents (DES) have reduced restenosis rates compared with bare-metal&#xD;
      stents, the restenosis rate is still high in the high-risk group. G protein plays important&#xD;
      roles in the signal transduction leading to vascular smooth muscle proliferation. The initial&#xD;
      and subsequent studies suggest that the T allele of C825T polymorphism is associated with&#xD;
      enhanced transmembrane signaling via Gi proteins.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">September 2012</completion_date>
  <primary_completion_date type="Anticipated">August 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>In-stent restenosis</measure>
    <time_frame>6-24months after stent implanting</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>target lesion revascularization (TLR)</measure>
    <time_frame>6-24months after stent implanting</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>re-myocardial infarction</measure>
    <time_frame>6-24months after stent implating</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>in-stent restenosis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>non-in-stent restenosis</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent follow-up angiography. All the patients must had been implanted&#xD;
             with DES during the last two years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For the non-ISR group, the patients underwent follow-up angiography less than 6 months&#xD;
             away from stent implanting.&#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_contact>
    <last_name>Yamei Xu</last_name>
    <phone>8613917133371</phone>
    <email>xu.yamei@zs-hospital.sh.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yamei Xu</last_name>
      <phone>8613917133371</phone>
      <email>xu.yamei@zs-hospital.sh.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>August 19, 2012</last_update_submitted>
  <last_update_submitted_qc>August 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>coronary stent implant</keyword>
  <keyword>polymorphism</keyword>
  <keyword>G protein</keyword>
  <keyword>drug-eluting stent</keyword>
  <keyword>restenosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT01670396
org study id: ZS-XN-ISR
nct id: NCT01670396
lead sponsor: 
has dmc: Yes
The investigators hypothesized that genetic variants of G protein influence the development
      of restenosis and clinical outcome of patients receiving drug-eluting stents (DES).
Although drug-eluting stents (DES) have reduced restenosis rates compared with bare-metal
      stents, the restenosis rate is still high in the high-risk group. G protein plays important
      roles in the signal transduction leading to vascular smooth muscle proliferation. The initial
      and subsequent studies suggest that the T allele of C825T polymorphism is associated with
      enhanced transmembrane signaling via Gi proteins.
observational model: Case-Control
time perspective: Retrospective
measure: In-stent restenosis
time frame: 6-24months after stent implanting
measure: target lesion revascularization (TLR)
time frame: 6-24months after stent implanting
measure: re-myocardial infarction
time frame: 6-24months after stent implating
arm group label: in-stent restenosis
arm group label: non-in-stent restenosis
whole blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yamei Xu
phone: 8613917133371
email: xu.yamei@zs-hospital.sh.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease