<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/NCT03841214</url>
  </required_header>
  <id_info>
    <org_study_id>TRUSTED</org_study_id>
    <nct_id>NCT03841214</nct_id>
  </id_info>
  <brief_title>Study on Prediction of Left Ventricular Remodeling Using ST2</brief_title>
  <acronym>TRUSTED</acronym>
  <official_title>Prediction of ST2 for impRovement of Left ventricUlar Systolic funcTion After Percutaneous Coronary Intervention in Patients With acutE Coronary synDrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keimyung University Dongsan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Keimyung University Dongsan Medical Center</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>
      Patients who underwent percutaneous coronary intervention after diagnosis of acute coronary&#xD;
      syndrome should be enrolled in the study and follow - up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obtain written consent for patients who meet all of the selection criteria and who do not&#xD;
      meet the exclusion criteria.&#xD;
&#xD;
      ACS(Acute Coronary Syndrome) patients with LV systolic dysfunction(LVEF&lt;50%) on TTE test who&#xD;
      underwent successful PCI. At that time, patient proceed with the Baseline blood test(ST2) in&#xD;
      hospital.&#xD;
&#xD;
      And then, Medical therapy for 3 months later patient proceed with the Follow-up blood&#xD;
      test(ST2) and TTE in OPD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 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>3 Months</target_duration>
  <primary_outcome>
    <measure>ST2 and LV end-diastolic volume index</measure>
    <time_frame>3 months</time_frame>
    <description>the correlation between changes of ST2 and LV end-diastolic volume index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ST2 and LV ejection fraction</measure>
    <time_frame>3 months</time_frame>
    <description>the correlation between changes of ST2 and LV ejection fraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ST2 and E over e' ratio</measure>
    <time_frame>3 months</time_frame>
    <description>the correlation between changes of ST2 and E over e' ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ST2 and LV wall motion score</measure>
    <time_frame>3 months</time_frame>
    <description>the correlation between changes of ST2 and LV wall motion score</description>
  </secondary_outcome>
  <enrollment type="Actual">114</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute coronary syndrome who underwent successful percutaneous coronary&#xD;
        intervention&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged 19 or older&#xD;
&#xD;
          -  Patients with acute coronary syndrome who underwent successful percutaneous coronary&#xD;
             intervention&#xD;
&#xD;
          -  Patients with left ventricular ejection fraction less than 50% on transthoracic&#xD;
             echocardiography&#xD;
&#xD;
          -  Patients who voluntarily agreed to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to obtain TIMI 3 flow after procedure&#xD;
&#xD;
          -  If the remaining life span is less than one year&#xD;
&#xD;
          -  Women who are breastfeeding or plan to become pregnant or are planning to become&#xD;
             pregnant during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyung-Seop Kim, Postdoctoral</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keimyung University Dongsan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keimyung University Dongsan Hospital</name>
      <address>
        <city>Daegu</city>
        <state>Dalseogu</state>
        <zip>42601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Keimyung University Dongsan Medical Center</investigator_affiliation>
    <investigator_full_name>Kim Hyungseop</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03841214
org study id: TRUSTED
nct id: NCT03841214
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients who underwent percutaneous coronary intervention after diagnosis of acute coronary
      syndrome should be enrolled in the study and follow - up.
Obtain written consent for patients who meet all of the selection criteria and who do not
      meet the exclusion criteria.

      ACS(Acute Coronary Syndrome) patients with LV systolic dysfunction(LVEF<50%) on TTE test who
      underwent successful PCI. At that time, patient proceed with the Baseline blood test(ST2) in
      hospital.

      And then, Medical therapy for 3 months later patient proceed with the Follow-up blood
      test(ST2) and TTE in OPD.
observational model: Cohort
time perspective: Prospective
measure: ST2 and LV end-diastolic volume index
time frame: 3 months
description: the correlation between changes of ST2 and LV end-diastolic volume index
measure: ST2 and LV ejection fraction
time frame: 3 months
description: the correlation between changes of ST2 and LV ejection fraction
measure: ST2 and E over e' ratio
time frame: 3 months
description: the correlation between changes of ST2 and E over e' ratio
measure: ST2 and LV wall motion score
time frame: 3 months
description: the correlation between changes of ST2 and LV wall motion score
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Hyung-Seop Kim, Postdoctoral
role: Principal Investigator
affiliation: Keimyung University Dongsan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Keimyung University Dongsan Medical Center
investigator full name: Kim Hyungseop
investigator title: Professor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome