<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/NCT04405856</url>
  </required_header>
  <id_info>
    <org_study_id>IABP-Jsph</org_study_id>
    <nct_id>NCT04405856</nct_id>
  </id_info>
  <brief_title>Outcome of Patients Treated With IABP</brief_title>
  <official_title>Outcome of Patients Treated With Intra Aortic Balloon Pump</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Medical University</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>
      Intra-Aortic Balloon Pumps (IABP) is a widely used and effective left ventricular adjuvant&#xD;
      therapy. IABP is an inflatable device placed in the aorta that inflates with diastole and&#xD;
      deflates with systole. The aim of this study is to investigate the outcome of patients&#xD;
      treated With IABP, and to evaluate the short-term and long-term outcomes of patients with&#xD;
      IABP.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2012</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>30 days after IABP implantation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>3 months after IABP implantation</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Cardiogenic Shock</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Heart Failure</condition>
  <condition>Left Ventricular Dysfunction</condition>
  <condition>Low Cardiac Output Syndrome</condition>
  <condition>Post-cardiac Surgery</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intra Aortic Balloon Pump</intervention_name>
    <description>Intra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receiving IABP for circulatory support&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving IABP for circulatory support&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Yong-feng Shao, MD</last_name>
    <role>Study Director</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hong Liu, MD</last_name>
    <phone>18801281613</phone>
    <email>DR.HONGLIU@FOXMAIL.COM</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yong-feng Shao, MD</last_name>
    <phone>02568303100</phone>
    <email>yfshaojph@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The first affiliated hospital of nanjing medical university</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Liu, MD</last_name>
      <phone>188012181613</phone>
      <email>dr.hongliu@foxmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Hong Liu</investigator_full_name>
    <investigator_title>Investigator of Department of Cardiac Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Ventricular Dysfunction</mesh_term>
    <mesh_term>Shock, Cardiogenic</mesh_term>
    <mesh_term>Ventricular Dysfunction, Left</mesh_term>
    <mesh_term>Cardiac Output, Low</mesh_term>
    <mesh_term>Syndrome</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/NCT04405856
org study id: IABP-Jsph
nct id: NCT04405856
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Intra-Aortic Balloon Pumps (IABP) is a widely used and effective left ventricular adjuvant
      therapy. IABP is an inflatable device placed in the aorta that inflates with diastole and
      deflates with systole. The aim of this study is to investigate the outcome of patients
      treated With IABP, and to evaluate the short-term and long-term outcomes of patients with
      IABP.
observational model: Cohort
time perspective: Prospective
measure: All-cause mortality
time frame: 30 days after IABP implantation
measure: All-cause mortality
time frame: 3 months after IABP implantation
intervention type: Device
intervention name: Intra Aortic Balloon Pump
description: Intra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 100 Years
last name: Yong-feng Shao, MD
role: Study Director
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Hong Liu, MD
phone: 18801281613
email: DR.HONGLIU@FOXMAIL.COM
last name: Yong-feng Shao, MD
phone: 02568303100
email: yfshaojph@sina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing Medical University
investigator full name: Hong Liu
investigator title: Investigator of Department of Cardiac Surgery
mesh term: Coronary Artery Disease
mesh term: Acute Coronary Syndrome
mesh term: Ventricular Dysfunction
mesh term: Shock, Cardiogenic
mesh term: Ventricular Dysfunction, Left
mesh term: Cardiac Output, Low
mesh term: Syndrome
sharing ipd: Undecided