<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/NCT02985008</url>
  </required_header>
  <id_info>
    <org_study_id>2016-03-130</org_study_id>
    <nct_id>NCT02985008</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock</brief_title>
  <acronym>SMART-RESCUE</acronym>
  <official_title>SMart Angioplasty Research Team: A Multi-center, Open, REtrospective and Prospective Observational Study to Investigate Clinical oUtcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock : RESCUE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeong Hoon Yang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic&#xD;
      manifolds and investigated the current state of treatment and clinical features of&#xD;
      cardiogenic shock in Koreans and identified the factors that could improve the prognosis and&#xD;
      the use of IABP and ECMO And to investigate its therapeutic effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. The selection / exclusion criteria for persons with cardiogenic shock should be verified&#xD;
           by medical records from January 1, 2014 before the approval date of each institution's&#xD;
           clinical trial screening committee.&#xD;
&#xD;
        2. If a cardiogenic shock to the selection criteria is found in the emergency room, general&#xD;
           ward, or intensive care unit of the participating institutions, enroll in this study and&#xD;
           fill in the information according to the e-CRF.&#xD;
&#xD;
        3. After 1, 6 and 12 months, visit the hospital for examination and procedures. The person&#xD;
           in charge of the examination or the delegate of the examiner may follow the person by&#xD;
           telephone or an outpatient visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>In hospital death</measure>
    <time_frame>for 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death in 28days</measure>
    <time_frame>28days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death in 1 year</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days of intensive care unit Number of days of intensive care unit</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospitalization days</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lactate 24 hour clearance</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful removal of left ventricular assist device (IABP, ECMO)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Shock, Cardiogenic</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Total: 1,000&#xD;
&#xD;
          -  Cardiogenic shock group with inserted IABP, ECMO : 400&#xD;
&#xD;
          -  Cardiogenic shock group without inserted IABP, ECMO : 600&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 19 years old or older&#xD;
&#xD;
          2. ① Systolic blood pressure is less than 90mmHg for more than 30 minutes despite the&#xD;
             fluid therapy, or Use of pressure boosting agents is necessary.&#xD;
&#xD;
             ② Peripheral hypopnea (cold skin, urine less than 30 cc per hour, impaired&#xD;
             consciousness, lactate ≥2.0 mmol / l) or a person with pulmonary edema.&#xD;
&#xD;
          3. Causes of cardiogenic shock include acute myocardial infarction (including in coronary&#xD;
             intervention), cardiomyopathy, myocarditis, pulmonary embolism, refractory ventricular&#xD;
             tachycardia, shock during coronary intervention.&#xD;
&#xD;
          4. Those voluntarily consenting to the medical records and the data necessary for the&#xD;
             study during the entire study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other causes except for cardiogenic shock (low blood pressure, septic, obstructive&#xD;
             shock)&#xD;
&#xD;
          2. Shock with cardiac arrest outside the hospital&#xD;
&#xD;
          3. People with allergic reactions to anticoagulants such as heparin.&#xD;
&#xD;
          4. Those who refused active treatment.&#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>Jeong Hoon Yang</last_name>
    <role>Study Chair</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jeong Hoon Yang</last_name>
    <phone>+82-10-4872-9433</phone>
    <email>jeonghoon.yang@samsung.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jin Hee Seo</last_name>
    <phone>+82-10-6623-5673</phone>
    <email>rufina.seo@samsung.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul City</city>
        <state>Seoul</state>
        <zip>KS013</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeong Hoon Yang</last_name>
      <email>jeonghoon.yang@samsung.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Thiele H, Allam B, Chatellier G, Schuler G, Lafont A. Shock in acute myocardial infarction: the Cape Horn for trials? Eur Heart J. 2010 Aug;31(15):1828-35. doi: 10.1093/eurheartj/ehq220. Epub 2010 Jul 7.</citation>
    <PMID>20610640</PMID>
  </reference>
  <reference>
    <citation>Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Bohm M, Ebelt H, Schneider S, Werdan K, Schuler G; Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet. 2013 Nov 16;382(9905):1638-45. doi: 10.1016/S0140-6736(13)61783-3. Epub 2013 Sep 3.</citation>
    <PMID>24011548</PMID>
  </reference>
  <reference>
    <citation>Rousse N, Juthier F, Pincon C, Hysi I, Banfi C, Robin E, Fayad G, Jegou B, Prat A, Vincentelli A. ECMO as a bridge to decision: Recovery, VAD, or heart transplantation? Int J Cardiol. 2015;187:620-7. doi: 10.1016/j.ijcard.2015.03.283. Epub 2015 Mar 20.</citation>
    <PMID>25863737</PMID>
  </reference>
  <reference>
    <citation>Napp LC, Brehm M, Kuhn C, Schafer A, Bauersachs J. Heart against veno-arterial ECMO: Competition visualized. Int J Cardiol. 2015;187:164-5. doi: 10.1016/j.ijcard.2015.03.311. Epub 2015 Mar 21. No abstract available.</citation>
    <PMID>25828345</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jeong Hoon Yang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Shock, IVBP, ECMO, In hospital death</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Cardiogenic</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <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/NCT02985008
org study id: 2016-03-130
nct id: NCT02985008
lead sponsor: 
has dmc: No
Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic
      manifolds and investigated the current state of treatment and clinical features of
      cardiogenic shock in Koreans and identified the factors that could improve the prognosis and
      the use of IABP and ECMO And to investigate its therapeutic effect.
1. The selection / exclusion criteria for persons with cardiogenic shock should be verified
           by medical records from January 1, 2014 before the approval date of each institution's
           clinical trial screening committee.

        2. If a cardiogenic shock to the selection criteria is found in the emergency room, general
           ward, or intensive care unit of the participating institutions, enroll in this study and
           fill in the information according to the e-CRF.

        3. After 1, 6 and 12 months, visit the hospital for examination and procedures. The person
           in charge of the examination or the delegate of the examiner may follow the person by
           telephone or an outpatient visit.
observational model: Cohort
measure: In hospital death
time frame: for 1 year
measure: Death in 28days
time frame: 28days
measure: Death in 1 year
time frame: 1 year
measure: Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up.
time frame: 1 year
measure: Number of days of intensive care unit Number of days of intensive care unit
time frame: 1 year
measure: hospitalization days
time frame: 1 year
measure: Lactate 24 hour clearance
time frame: 1 year
measure: Successful removal of left ventricular assist device (IABP, ECMO)
time frame: 1 year
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Jeong Hoon Yang
role: Study Chair
affiliation: Samsung Medical Center
last name: Jeong Hoon Yang
phone: +82-10-4872-9433
email: jeonghoon.yang@samsung.com
last name: Jin Hee Seo
phone: +82-10-6623-5673
email: rufina.seo@samsung.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: Thiele H, Allam B, Chatellier G, Schuler G, Lafont A. Shock in acute myocardial infarction: the Cape Horn for trials? Eur Heart J. 2010 Aug;31(15):1828-35. doi: 10.1093/eurheartj/ehq220. Epub 2010 Jul 7.
PMID: 20610640
citation: Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Bohm M, Ebelt H, Schneider S, Werdan K, Schuler G; Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet. 2013 Nov 16;382(9905):1638-45. doi: 10.1016/S0140-6736(13)61783-3. Epub 2013 Sep 3.
PMID: 24011548
citation: Rousse N, Juthier F, Pincon C, Hysi I, Banfi C, Robin E, Fayad G, Jegou B, Prat A, Vincentelli A. ECMO as a bridge to decision: Recovery, VAD, or heart transplantation? Int J Cardiol. 2015;187:620-7. doi: 10.1016/j.ijcard.2015.03.283. Epub 2015 Mar 20.
PMID: 25863737
citation: Napp LC, Brehm M, Kuhn C, Schafer A, Bauersachs J. Heart against veno-arterial ECMO: Competition visualized. Int J Cardiol. 2015;187:164-5. doi: 10.1016/j.ijcard.2015.03.311. Epub 2015 Mar 21. No abstract available.
PMID: 25828345
responsible party type: Sponsor-Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jeong Hoon Yang
investigator title: Professor
mesh term: Shock, Cardiogenic
mesh term: Shock
sharing ipd: Undecided