<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/NCT03776266</url>
  </required_header>
  <id_info>
    <org_study_id>SMC 2018-10-044</org_study_id>
    <nct_id>NCT03776266</nct_id>
  </id_info>
  <brief_title>The Long-term Clinical Outcomes and Patterns of Transfusion in PCI Patients: Retrospective Cohort Study</brief_title>
  <acronym>TFPCI</acronym>
  <official_title>The Five-year Pattern of Red Blood Cell Transfusion and Clinical Outcome in Patients Undergoing Percutaneous Coronary Intervention: A Korean Nationwide Longitudinal Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A nationwide retrospective cohort study. To investigate the long-term patterns of transfusion&#xD;
      and clinical outcomes of patients undergoing PCI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A nationwide retrospective cohort study. Transfusion after PCI may increase a risk, but the&#xD;
      long term effects after red blood cell transfusion is known. Longitudinal data is collected&#xD;
      from administrative claims in the National Healthcare Insurance Service of Korea. All Korean&#xD;
      patient date undergoing PCI inserting stent from January 1, 2011 to December 31, 2011 is&#xD;
      extracted. Clinical outcomes until December 31, 2016 is investigated.&#xD;
&#xD;
      Primary outcome is the incidence density of red blood cell transfusion. Secondary outcomes&#xD;
      are the association of transfusion with major adverse clinical event (MACE) consisting&#xD;
      all-cause death, revascularization, critically ill cardiovascular status, or stroke.&#xD;
&#xD;
      Incidence density and time-dependent Cox proportional hazard regression is statistically&#xD;
      analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2018</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence density of transfusion</measure>
    <time_frame>5 years</time_frame>
    <description>5-year incidence density of red blood cell transfusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence density of MACE</measure>
    <time_frame>5 years</time_frame>
    <description>5-year incidence densities of a major adverse clinical event (MACE) consisting of all-cause death, revascularization, critically ill cardiovascular status, and stroke</description>
  </secondary_outcome>
  <enrollment type="Actual">48786</enrollment>
  <condition>Erythrocyte Transfusion</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <condition>Revascularization</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No intervention is required due to retrospective observational study</intervention_name>
    <description>Red blood cell transfusion on or after percutaneous coronary intervention</description>
    <other_name>Observation on Red blood cell transfusion on or after percutaneous coronary intervention</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing PCI using stent in 2011 from all medical providers in Korea is&#xD;
        selected using National Healthcare Insurance System&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All Korean patients undergoing PCI using stent from January 1, 2011 to December 31,&#xD;
             2011&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without any stent insertion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Ho Choi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Gang nam-Gu, Ilwon-Dong</state>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jin-Ho Choi</investigator_full_name>
    <investigator_title>MD, PhD, Professor</investigator_title>
  </responsible_party>
  <keyword>Transfusion</keyword>
  <keyword>PCI</keyword>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03776266
org study id: SMC 2018-10-044
nct id: NCT03776266
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A nationwide retrospective cohort study. To investigate the long-term patterns of transfusion
      and clinical outcomes of patients undergoing PCI.
A nationwide retrospective cohort study. Transfusion after PCI may increase a risk, but the
      long term effects after red blood cell transfusion is known. Longitudinal data is collected
      from administrative claims in the National Healthcare Insurance Service of Korea. All Korean
      patient date undergoing PCI inserting stent from January 1, 2011 to December 31, 2011 is
      extracted. Clinical outcomes until December 31, 2016 is investigated.

      Primary outcome is the incidence density of red blood cell transfusion. Secondary outcomes
      are the association of transfusion with major adverse clinical event (MACE) consisting
      all-cause death, revascularization, critically ill cardiovascular status, or stroke.

      Incidence density and time-dependent Cox proportional hazard regression is statistically
      analyzed.
observational model: Cohort
time perspective: Retrospective
measure: Incidence density of transfusion
time frame: 5 years
description: 5-year incidence density of red blood cell transfusion
measure: Incidence density of MACE
time frame: 5 years
description: 5-year incidence densities of a major adverse clinical event (MACE) consisting of all-cause death, revascularization, critically ill cardiovascular status, and stroke
intervention type: Procedure
intervention name: No intervention is required due to retrospective observational study
description: Red blood cell transfusion on or after percutaneous coronary intervention
other name: Observation on Red blood cell transfusion on or after percutaneous coronary intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jin-Ho Choi, MD, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jin-Ho Choi
investigator title: MD, PhD, Professor
sharing ipd: Undecided