<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/NCT03238508</url>
  </required_header>
  <id_info>
    <org_study_id>Sejong_IRB_1732</org_study_id>
    <nct_id>NCT03238508</nct_id>
  </id_info>
  <brief_title>Index of Microcirculatory Resistance After Immediate Versus Deferred Stenting in Patients With Acute Myocardial Infarction</brief_title>
  <official_title>Index of Microcirculatory Resistance After Immediate Versus Deferred Stenting in Patients With Acute Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sejong General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sejong General Hospital</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>
      This study will compare the microcirculatory resistance (IMR) of infarct-related artery (IRA)&#xD;
      in patients who underwent immediate versus deferred stenting during percutaneous coronary&#xD;
      intervention (PCI) for acute myocardial infarction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary PCI with immediate stenting (IS) is the current standard of reperfusion strategy for&#xD;
      STEMI. However, it is thought that IS may cause additional myocardial injury by increasing&#xD;
      distal embolization of clot and atheromatous plaque debris. Only about 35% of patients&#xD;
      without cardiogenic shock can achieve optimal myocardial tissue perfusion at the&#xD;
      microvascular level, even after restoration of epicardial coronary artery patency. IS in&#xD;
      highly pro-thrombotic and inflammatory milieu of IRA during primary PCI would increase distal&#xD;
      embolization of clot and atheromatous plaque debris, and provoke the inflammation process, so&#xD;
      deferred stenting after a cooling down period of IRA for several days, have a potential to&#xD;
      mitigate or prevent microvascular obstruction (MVO). Among several methods to evaluate MVO&#xD;
      after STEMI, IMR has been well known as an good indicator of MVO and strong predictor for&#xD;
      short and long term clinical outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Anticipated">September 30, 2017</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Index of microcirculatory resistance of infarct-related artery</measure>
    <time_frame>3 to 5 days after primary reperfusion (TIMI 3 flow achievement) in both groups</time_frame>
    <description>Measured by pressure and temperature sensors- tipped guide wire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of urgent revascularization</measure>
    <time_frame>During index hospitalization (intraoperative)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>During index hospitalization (intraoperative)</time_frame>
    <description>Defined as TIMI bleeding criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac events</measure>
    <time_frame>One- year after primary reperfusion</time_frame>
    <description>Death, myocardial infarction, unplanned target vessel revascularization or CHF admission</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Immediate stenting group</arm_group_label>
    <description>Conventional stenting immediate after the re-opening of infarct-related artery during primary PCI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deferred stenting group</arm_group_label>
    <description>Elective stenting following cooling down of infarct- related artery for several days after restoration of epicardial coronary blood flow during primary PCI</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deferred stenting</intervention_name>
    <description>Previously described</description>
    <arm_group_label>Deferred stenting group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing primary precutaneous coronary intervention for ST- segment elevation or&#xD;
        Non ST-segment elevation myocardial infarcation with ongoing myocardial ischemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. More than 30 minutes in duration of typical chest pain&#xD;
&#xD;
          2. Thrombolysis In Myocardial Infarction (TIMI) flow 0, 1 or 2 prior to the procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cardiogenic shock,&#xD;
&#xD;
          2. Previous history of myocardial infarction, or coronary artery bypass surgery&#xD;
&#xD;
          3. Rescue PCI after fibrinolysis&#xD;
&#xD;
          4. Life expectancy of less than 1 year&#xD;
&#xD;
          5. Acute occlusion of left main coronary artery&#xD;
&#xD;
          6. STEMI due to stent thrombosis&#xD;
&#xD;
          7. Major coronary dissection (type D~F) following procedures achieving TIMI 3 flow&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyun Jong Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sejong General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hyun Jong Lee, MD</last_name>
    <phone>82-32-340-1812</phone>
    <email>untouchables@sejongh.co.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu</name>
      <address>
        <city>Bucheon</city>
        <state>Gyeonggi</state>
        <zip>422-711</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hyun-Jong Lee, MD</last_name>
      <phone>82-32-340-1812</phone>
      <email>untouchables@sejongh.co.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Kim JS, Lee HJ, Woong Yu C, Kim YM, Hong SJ, Park JH, Choi RK, Choi YJ, Park JS, Kim TH, Jang HJ, Joo HJ, Cho SA, Ro YM, Lim DS. INNOVATION Study (Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-Segment-Elevation Myocardial Infarction). Circ Cardiovasc Interv. 2016 Dec;9(12):e004101. doi: 10.1161/CIRCINTERVENTIONS.116.004101.</citation>
    <PMID>27965296</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sejong General Hospital</investigator_affiliation>
    <investigator_full_name>Hyun Jong Lee</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Deferred stenting</keyword>
  <keyword>Microvascular dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03238508
org study id: Sejong_IRB_1732
nct id: NCT03238508
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will compare the microcirculatory resistance (IMR) of infarct-related artery (IRA)
      in patients who underwent immediate versus deferred stenting during percutaneous coronary
      intervention (PCI) for acute myocardial infarction.
Primary PCI with immediate stenting (IS) is the current standard of reperfusion strategy for
      STEMI. However, it is thought that IS may cause additional myocardial injury by increasing
      distal embolization of clot and atheromatous plaque debris. Only about 35% of patients
      without cardiogenic shock can achieve optimal myocardial tissue perfusion at the
      microvascular level, even after restoration of epicardial coronary artery patency. IS in
      highly pro-thrombotic and inflammatory milieu of IRA during primary PCI would increase distal
      embolization of clot and atheromatous plaque debris, and provoke the inflammation process, so
      deferred stenting after a cooling down period of IRA for several days, have a potential to
      mitigate or prevent microvascular obstruction (MVO). Among several methods to evaluate MVO
      after STEMI, IMR has been well known as an good indicator of MVO and strong predictor for
      short and long term clinical outcomes.
observational model: Case-Control
time perspective: Prospective
measure: Index of microcirculatory resistance of infarct-related artery
time frame: 3 to 5 days after primary reperfusion (TIMI 3 flow achievement) in both groups
description: Measured by pressure and temperature sensors- tipped guide wire
measure: The rate of urgent revascularization
time frame: During index hospitalization (intraoperative)
measure: Major bleeding
time frame: During index hospitalization (intraoperative)
description: Defined as TIMI bleeding criteria
measure: Major adverse cardiac events
time frame: One- year after primary reperfusion
description: Death, myocardial infarction, unplanned target vessel revascularization or CHF admission
arm group label: Immediate stenting group
description: Conventional stenting immediate after the re-opening of infarct-related artery during primary PCI
arm group label: Deferred stenting group
description: Elective stenting following cooling down of infarct- related artery for several days after restoration of epicardial coronary blood flow during primary PCI
intervention type: Procedure
intervention name: Deferred stenting
description: Previously described
arm group label: Deferred stenting group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hyun Jong Lee, MD
role: Principal Investigator
affiliation: Sejong General Hospital
last name: Hyun Jong Lee, MD
phone: 82-32-340-1812
email: untouchables@sejongh.co.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: Kim JS, Lee HJ, Woong Yu C, Kim YM, Hong SJ, Park JH, Choi RK, Choi YJ, Park JS, Kim TH, Jang HJ, Joo HJ, Cho SA, Ro YM, Lim DS. INNOVATION Study (Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-Segment-Elevation Myocardial Infarction). Circ Cardiovasc Interv. 2016 Dec;9(12):e004101. doi: 10.1161/CIRCINTERVENTIONS.116.004101.
PMID: 27965296
responsible party type: Principal Investigator
investigator affiliation: Sejong General Hospital
investigator full name: Hyun Jong Lee
investigator title: Principle Investigator
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No