<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/NCT03766529</url>
  </required_header>
  <id_info>
    <org_study_id>LiuPhD</org_study_id>
    <nct_id>NCT03766529</nct_id>
  </id_info>
  <brief_title>Loop Isolation-based Uploading Pre-conditioning</brief_title>
  <official_title>Loop Isolation-based Uploading Pre-conditioning to Protect Heart From Ischemic-Reperfusion Damage in Coronary Artery Bypass Surgery</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Myocardial protection is of crucial importance for surgical coronary revascularization in&#xD;
      patients with ischaemic heart diseases. The investigators proposed loop isolation-based&#xD;
      uploading preconditioning to protect heart from ischemic-reperfusion damage (LiuPhD) as a&#xD;
      novel cardioprotective strategy, and applied to patients who underwent on-pump coronary&#xD;
      artery bypass grafting (CABG).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Myocardial protection is of crucial importance for surgical coronary revascularization in&#xD;
      patients with ischaemic heart diseases. Considerable effort has been made to optimize&#xD;
      cardioprotective strategy for improving cardiac performances after global myocardial&#xD;
      ischemia. Of various strategies, terminal warm blood cardioplegia (TWBC) delivery has been&#xD;
      proven to be effective in reducing risk of ischemic attack at the time of myocardial&#xD;
      reperfusion. Based on TWBC strategy and Frank-Starling law of heart, the investigators&#xD;
      proposed loop isolation-based uploading preconditioning to protect heart from&#xD;
      ischemic-reperfusion damage (LiuPhD) as a novel myocardial protective strategy, which&#xD;
      procedurally renders coronary loop via brief warm blood delivery independent of&#xD;
      extracorporeal loop following TWBC delivery just before declamping. The investigators&#xD;
      hypothesize that LiuPhD strategy allows myocardial cells complete depolarization and drives&#xD;
      heart into zero-loading heat cycles, contributing to enhancing myocardial physiologic reserve&#xD;
      and improving cardiac initiative capacity responding to upcoming loading increases after&#xD;
      onset of clamp release. The aim of the present study was to determine whether LiuPhD strategy&#xD;
      during on-pump coronary artery bypass grafting (CABG) can attenuate reperfusion injury after&#xD;
      global myocardial ischemia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration of postoperative maximum cardiac troponin T</measure>
    <time_frame>up to 30 days</time_frame>
    <description>postoperative maximum concentration serum cardiac troponin T (cTnT) as markers of myocardial injury.</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Ischaemic Heart Diseases</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>loop isolation-based uploading preconditioning (LiuPhD)</intervention_name>
    <description>declamping was not done until heart could resume normal mechanical activities and sustain well for three minutes in terms of heart rate, rhythm, and myocardial contractility via continuous antegrade warm blood delivery closely following TWBC reperfusion.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The LiuPhD (Loop Isolation-based Uploading Preconditioning to Protect Heart from&#xD;
        ischemic-reperfusion Damage) study was a prospective, open-label, single-arm, first-in-man&#xD;
        trial on the use of LiuPhD strategy for myocardial protection in patients who underwent&#xD;
        surgical coronary revascularization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for a first, elective, isolated, open thoracotomy, on-pump CABG&#xD;
             were eligible for enrollment if they if they had coronary angiography-confirmed&#xD;
             unprotected left main disease, 3-vessel disease with or without proximal LAD artery&#xD;
             disease, or 2-vessel disease with proximal LAD artery disease.&#xD;
&#xD;
          -  Inclusion criteria were evidence of preserved left ventricular function (LVEF≥35%) and&#xD;
             normal or mild pulmonary hypertension (sPAP&lt;50mmHg).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria were secondary CABG, emergency CABG, conversion operations form&#xD;
             off-pump CABG or minimally invasive CABG surgery, or any additional cardiac lesions&#xD;
             necessitating concomitant surgery, as well as being considered too high risk for&#xD;
             surgical revascularization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hong Liu, MD</last_name>
    <phone>8618801281613</phone>
    <email>dr.hongliu@foxmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>TEDA International Cardiovascular Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300457</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>December 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</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>Clinical Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</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/NCT03766529
org study id: LiuPhD
nct id: NCT03766529
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Myocardial protection is of crucial importance for surgical coronary revascularization in
      patients with ischaemic heart diseases. The investigators proposed loop isolation-based
      uploading preconditioning to protect heart from ischemic-reperfusion damage (LiuPhD) as a
      novel cardioprotective strategy, and applied to patients who underwent on-pump coronary
      artery bypass grafting (CABG).
Myocardial protection is of crucial importance for surgical coronary revascularization in
      patients with ischaemic heart diseases. Considerable effort has been made to optimize
      cardioprotective strategy for improving cardiac performances after global myocardial
      ischemia. Of various strategies, terminal warm blood cardioplegia (TWBC) delivery has been
      proven to be effective in reducing risk of ischemic attack at the time of myocardial
      reperfusion. Based on TWBC strategy and Frank-Starling law of heart, the investigators
      proposed loop isolation-based uploading preconditioning to protect heart from
      ischemic-reperfusion damage (LiuPhD) as a novel myocardial protective strategy, which
      procedurally renders coronary loop via brief warm blood delivery independent of
      extracorporeal loop following TWBC delivery just before declamping. The investigators
      hypothesize that LiuPhD strategy allows myocardial cells complete depolarization and drives
      heart into zero-loading heat cycles, contributing to enhancing myocardial physiologic reserve
      and improving cardiac initiative capacity responding to upcoming loading increases after
      onset of clamp release. The aim of the present study was to determine whether LiuPhD strategy
      during on-pump coronary artery bypass grafting (CABG) can attenuate reperfusion injury after
      global myocardial ischemia.
observational model: Cohort
time perspective: Prospective
measure: Concentration of postoperative maximum cardiac troponin T
time frame: up to 30 days
description: postoperative maximum concentration serum cardiac troponin T (cTnT) as markers of myocardial injury.
intervention type: Procedure
intervention name: loop isolation-based uploading preconditioning (LiuPhD)
description: declamping was not done until heart could resume normal mechanical activities and sustain well for three minutes in terms of heart rate, rhythm, and myocardial contractility via continuous antegrade warm blood delivery closely following TWBC reperfusion.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
last name: Hong Liu, MD
phone: 8618801281613
email: dr.hongliu@foxmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing Medical University
investigator full name: Hong Liu
investigator title: Clinical Investigator
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
sharing ipd: Undecided