<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/NCT03786965</url>
  </required_header>
  <id_info>
    <org_study_id>№22/18-H</org_study_id>
    <nct_id>NCT03786965</nct_id>
  </id_info>
  <brief_title>Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.</brief_title>
  <acronym>MPO-CSP</acronym>
  <official_title>Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Petersburg State Pavlov Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Petersburg State Pavlov Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The main objection is to investigate molecular biology of myocardial damage during cardiac&#xD;
      surgery procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess outcomes after cardiac surgery procedures. To investigate serum level of&#xD;
      myeloperoxidase, morphology of left atrium appendage, to perform genetic analysis and cell&#xD;
      biology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Anticipated">December 20, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 20, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Death within 30 days after procedure.</measure>
    <time_frame>within 30 days after procedure.</time_frame>
    <description>Death within 30 days after surgical procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute myocardial infarction.</measure>
    <time_frame>within 30 days after procedure.</time_frame>
    <description>Acute myocardial infarction (ST-changes with troponin I &gt; 10 ng/ml).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke.</measure>
    <time_frame>within 30 days after procedure.</time_frame>
    <description>Stroke (MRI changes or corresponding neurologist record).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arrhythmia</measure>
    <time_frame>within 30 days after procedure.</time_frame>
    <description>Any type of arrhythmia including AV-block.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal dysfunction.</measure>
    <time_frame>within 30 days after procedure.</time_frame>
    <description>Renal dysfunction if serum creatinine greater than 25% of upper reference range.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infection or febrile.</measure>
    <time_frame>within 30 days after procedure.</time_frame>
    <description>Infection or febrile (t&gt; 37 or CRP elevation or long regeneration of surgical wound).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory dysfunction.</measure>
    <time_frame>within 30 days after procedure.</time_frame>
    <description>Respiratory dysfunction (pulmonary ventilation longer than 2 days).</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Cardiac Procedure Complication</condition>
  <condition>Ischemic Heart Disease</condition>
  <condition>Valve Heart Disease</condition>
  <condition>Defect Septal</condition>
  <arm_group>
    <arm_group_label>On-pump CABG.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>On-pump CABG.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Off-pump CABG.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Off-pump CABG.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pump-assisted CABG.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Pump-assisted CABG.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heart Valve Procedure without CABG.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Heart Valve Procedure without CABG.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heart Valve Procedure with CABG.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Heart Valve Procedure with CABG.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>On-pump CABG</intervention_name>
    <description>On-pump CABG</description>
    <arm_group_label>On-pump CABG.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Off-pump CABG</intervention_name>
    <description>Off-pump CABG</description>
    <arm_group_label>Off-pump CABG.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pump-assisted CABG</intervention_name>
    <description>Pump-assisted CABG</description>
    <arm_group_label>Pump-assisted CABG.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Valve Repair Procedure without CABG.</intervention_name>
    <description>Valve Repair Procedure without CABG (open heart procedure).</description>
    <arm_group_label>Heart Valve Procedure without CABG.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Valve Repair Procedure with CABG.</intervention_name>
    <description>Valve Repair Procedure with CABG (open heart procedure).</description>
    <arm_group_label>Heart Valve Procedure with CABG.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ischemic heart disease with indications for operation&#xD;
&#xD;
          -  valve disease with indications for operation&#xD;
&#xD;
          -  ischemic heart disease combined with valve disease with indications for operation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander Nemkov, PhD</last_name>
    <role>Study Director</role>
    <affiliation>First Saint-Petersburg Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alexander Nemkov, PhD</last_name>
    <phone>+7-921-795-00-47</phone>
    <email>nemk_as@mail.ru</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vladimir Komok, PhD</last_name>
    <phone>+7-904-632-19-00</phone>
    <email>vladimir_komok@mail.ru</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nikolai Bunenkov</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Non-US/Non-Canadian</state>
        <zip>194358</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nikolay Bunenkov</last_name>
      <phone>+7-950-028-17-40</phone>
      <email>bunenkov2006@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Vladimir V Komok, Ph.D</last_name>
      <phone>+7 904 632 19 00</phone>
      <email>vladimir_komok@mail.ru</email>
    </contact_backup>
    <investigator>
      <last_name>Nikolai S Bunenkov</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aleksey V Sokolov, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>November 14, 2021</last_update_submitted>
  <last_update_submitted_qc>November 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Petersburg State Pavlov Medical University</investigator_affiliation>
    <investigator_full_name>Aleksandr Nemkov</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Ischemic Heart Disease</keyword>
  <keyword>Valve Disease</keyword>
  <keyword>Septal Defect</keyword>
  <keyword>Myeloperoxidase</keyword>
  <keyword>Molecular biology</keyword>
  <keyword>Gene analysis</keyword>
  <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>
    <mesh_term>Heart Valve Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data are confidential.</ipd_description>
  </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/NCT03786965
org study id: №22/18-H
nct id: NCT03786965
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main objection is to investigate molecular biology of myocardial damage during cardiac
      surgery procedures.
To assess outcomes after cardiac surgery procedures. To investigate serum level of
      myeloperoxidase, morphology of left atrium appendage, to perform genetic analysis and cell
      biology.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Death within 30 days after procedure.
time frame: within 30 days after procedure.
description: Death within 30 days after surgical procedure.
measure: Acute myocardial infarction.
time frame: within 30 days after procedure.
description: Acute myocardial infarction (ST-changes with troponin I > 10 ng/ml).
measure: Stroke.
time frame: within 30 days after procedure.
description: Stroke (MRI changes or corresponding neurologist record).
measure: Arrhythmia
time frame: within 30 days after procedure.
description: Any type of arrhythmia including AV-block.
measure: Renal dysfunction.
time frame: within 30 days after procedure.
description: Renal dysfunction if serum creatinine greater than 25% of upper reference range.
measure: Infection or febrile.
time frame: within 30 days after procedure.
description: Infection or febrile (t> 37 or CRP elevation or long regeneration of surgical wound).
measure: Respiratory dysfunction.
time frame: within 30 days after procedure.
description: Respiratory dysfunction (pulmonary ventilation longer than 2 days).
arm group label: On-pump CABG.
arm group type: Other
description: On-pump CABG.
arm group label: Off-pump CABG.
arm group type: Other
description: Off-pump CABG.
arm group label: Pump-assisted CABG.
arm group type: Other
description: Pump-assisted CABG.
arm group label: Heart Valve Procedure without CABG.
arm group type: Other
description: Heart Valve Procedure without CABG.
arm group label: Heart Valve Procedure with CABG.
arm group type: Other
description: Heart Valve Procedure with CABG.
intervention type: Other
intervention name: On-pump CABG
description: On-pump CABG
arm group label: On-pump CABG.
intervention type: Other
intervention name: Off-pump CABG
description: Off-pump CABG
arm group label: Off-pump CABG.
intervention type: Other
intervention name: Pump-assisted CABG
description: Pump-assisted CABG
arm group label: Pump-assisted CABG.
intervention type: Other
intervention name: Valve Repair Procedure without CABG.
description: Valve Repair Procedure without CABG (open heart procedure).
arm group label: Heart Valve Procedure without CABG.
intervention type: Other
intervention name: Valve Repair Procedure with CABG.
description: Valve Repair Procedure with CABG (open heart procedure).
arm group label: Heart Valve Procedure with CABG.
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Alexander Nemkov, PhD
role: Study Director
affiliation: First Saint-Petersburg Medical University
last name: Alexander Nemkov, PhD
phone: +7-921-795-00-47
email: nemk_as@mail.ru
last name: Vladimir Komok, PhD
phone: +7-904-632-19-00
email: vladimir_komok@mail.ru
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: St. Petersburg State Pavlov Medical University
investigator full name: Aleksandr Nemkov
investigator title: PhD
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Heart Valve Diseases
sharing ipd: No
ipd description: Individual participant data are confidential.