<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/NCT03786939</url>
  </required_header>
  <id_info>
    <org_study_id>EOCABG</org_study_id>
    <nct_id>NCT03786939</nct_id>
  </id_info>
  <brief_title>Evaluation of Outcomes of Coronary Artery Bypass Grafting.</brief_title>
  <acronym>EOCABG</acronym>
  <official_title>Evaluation of Outcomes of Coronary Artery Bypass Grafting.</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>
      Evaluation of outcomes of coronary artery bypass grafting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation of outcomes of coronary artery bypass grafting (CABG) on-, off- pump, pump&#xD;
      assisted as well as bimammary coronary artery bypass grafting.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To assess myocardial ischemic-reperfusion damage during different kinds of CABG.&#xD;
&#xD;
      To assess complications after during different kinds of CABG.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Anticipated">December 20, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 20, 2023</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Death.</measure>
    <time_frame>30 days during in stay.</time_frame>
    <description>Death during in-stay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death over 1 year after CABG.</measure>
    <time_frame>1 year.</time_frame>
    <description>Death over 1 year after CABG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death over 3 year after CABG.</measure>
    <time_frame>within 3 years.</time_frame>
    <description>Death over 3 year after CABG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death over 5 year after CABG.</measure>
    <time_frame>within 5 years.</time_frame>
    <description>Death over 5 year after CABG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute myocardial infarction after CABG.</measure>
    <time_frame>within 30 days after CABG</time_frame>
    <description>Acute myocardial infarction (Criteria: troponin I&gt;10+ST-elevation ECG+hemodynamic instability - record in medical history ot Cardiac Index&lt;2.3).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute myocardial infarction after CABG.</measure>
    <time_frame>within 1 year after CABG</time_frame>
    <description>Acute myocardial infarction (Criteria: troponin I&gt;0.05+ST-elevation on ECG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute myocardial infarction after CABG.</measure>
    <time_frame>within 3 years after CABG</time_frame>
    <description>Acute myocardial infarction (Criteria: troponin I&gt;0.05+ST-elevation on ECG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute myocardial infarction after CABG.</measure>
    <time_frame>within 5 years after CABG</time_frame>
    <description>Acute myocardial infarction (Criteria: troponin I&gt;0.05+ST-elevation on ECG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shunt dysfunction during 30 days after CABG.</measure>
    <time_frame>within 30 days after CABG</time_frame>
    <description>Criteria: Stenosis or occlusion of graft on coronary angiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shunt dysfunction during 1 year after CABG.</measure>
    <time_frame>within 1 year after CABG</time_frame>
    <description>Criteria: Stenosis or occlusion of graft on coronary angiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shunt dysfunction during 3 years after CABG.</measure>
    <time_frame>within 3 years after CABG</time_frame>
    <description>Criteria: Stenosis or occlusion of graft on coronary angiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shunt dysfunction during 5 years after CABG.</measure>
    <time_frame>within 5 years after CABG</time_frame>
    <description>Criteria: Stenosis or occlusion of graft on coronary angiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke.</measure>
    <time_frame>within 30 days after CABG</time_frame>
    <description>Stroke after CABG (Record of neurologist in medical history or/and MRI findings).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Dysfunction.</measure>
    <time_frame>within 30 days after CABG</time_frame>
    <description>Increase serum creatinine level greater than 25% of reference value after CABG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation.</measure>
    <time_frame>within 30 days after CABG</time_frame>
    <description>New onset of atrial fibrillation after CABG (ECG findings: f-waves).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IABP</measure>
    <time_frame>within 30 days after CABG</time_frame>
    <description>Intra-Aortic Balloon Pump (non - planned intervention aftet CABG due to hemodinamic instability (Cardiac Index &lt;2.3))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection or febrile.</measure>
    <time_frame>within 30 days after CABG</time_frame>
    <description>Infection or febrile (leucocytosis &gt; 9.0 more than 7 days after CABG or CRP &gt; 10 or t&gt;37.0 more than 7 days after CABG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual myocardial ischemia.</measure>
    <time_frame>within 30 days after CABG</time_frame>
    <description>New onset of myocardial contractility deterioration on echocardiography (with or without strain, documented hypokinetic or akinetic wall motion).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <condition>Coronary Artery Bypass Grafting</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>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>On-pump CABG.</intervention_name>
    <description>On-pump coronary artery bypass grafting.</description>
    <arm_group_label>On-pump CABG.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Off-pump CABG.</intervention_name>
    <description>Off-pump coronary artery bypass grafting.</description>
    <arm_group_label>Off-pump CABG.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pump-assisted CABG.</intervention_name>
    <description>Pump-assisted CABG.</description>
    <arm_group_label>Pump-assisted CABG.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ischemic heart disease with indications for coronary artery bypass grafting.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  valve disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander Nemkov, PhD</last_name>
    <role>Study Director</role>
    <affiliation>First State Pavlov 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>First Pavlov State Medical University</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197089</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vladimir Komok, Ph.D</last_name>
      <phone>+7 904 632 19 00</phone>
      <email>vladimir_komok@mail.ru</email>
    </contact>
    <contact_backup>
      <last_name>Nikolay Bunenkov</last_name>
      <phone>+7 921 795 00 45</phone>
      <email>bunenkov2006@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Nikolai Bunenkov</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aleksey Sokolov, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>October 2022</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>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ischemic Heart Disease</keyword>
  <keyword>coronary artery bypass grafting</keyword>
  <keyword>on-pump CABG</keyword>
  <keyword>off-pump CABG</keyword>
  <keyword>pump - assisted CABG</keyword>
  <keyword>myeloperoxidase after CABG</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>
  </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/NCT03786939
org study id: EOCABG
nct id: NCT03786939
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation of outcomes of coronary artery bypass grafting.
Evaluation of outcomes of coronary artery bypass grafting (CABG) on-, off- pump, pump
      assisted as well as bimammary coronary artery bypass grafting.

      Objective:

      To assess myocardial ischemic-reperfusion damage during different kinds of CABG.

      To assess complications after during different kinds of CABG.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Death.
time frame: 30 days during in stay.
description: Death during in-stay.
measure: Death over 1 year after CABG.
time frame: 1 year.
description: Death over 1 year after CABG.
measure: Death over 3 year after CABG.
time frame: within 3 years.
description: Death over 3 year after CABG.
measure: Death over 5 year after CABG.
time frame: within 5 years.
description: Death over 5 year after CABG.
measure: Acute myocardial infarction after CABG.
time frame: within 30 days after CABG
description: Acute myocardial infarction (Criteria: troponin I>10+ST-elevation ECG+hemodynamic instability - record in medical history ot Cardiac Index<2.3).
measure: Acute myocardial infarction after CABG.
time frame: within 1 year after CABG
description: Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).
measure: Acute myocardial infarction after CABG.
time frame: within 3 years after CABG
description: Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).
measure: Acute myocardial infarction after CABG.
time frame: within 5 years after CABG
description: Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).
measure: Shunt dysfunction during 30 days after CABG.
time frame: within 30 days after CABG
description: Criteria: Stenosis or occlusion of graft on coronary angiography.
measure: Shunt dysfunction during 1 year after CABG.
time frame: within 1 year after CABG
description: Criteria: Stenosis or occlusion of graft on coronary angiography.
measure: Shunt dysfunction during 3 years after CABG.
time frame: within 3 years after CABG
description: Criteria: Stenosis or occlusion of graft on coronary angiography.
measure: Shunt dysfunction during 5 years after CABG.
time frame: within 5 years after CABG
description: Criteria: Stenosis or occlusion of graft on coronary angiography.
measure: Stroke.
time frame: within 30 days after CABG
description: Stroke after CABG (Record of neurologist in medical history or/and MRI findings).
measure: Renal Dysfunction.
time frame: within 30 days after CABG
description: Increase serum creatinine level greater than 25% of reference value after CABG.
measure: Atrial fibrillation.
time frame: within 30 days after CABG
description: New onset of atrial fibrillation after CABG (ECG findings: f-waves).
measure: IABP
time frame: within 30 days after CABG
description: Intra-Aortic Balloon Pump (non - planned intervention aftet CABG due to hemodinamic instability (Cardiac Index <2.3))
measure: Infection or febrile.
time frame: within 30 days after CABG
description: Infection or febrile (leucocytosis > 9.0 more than 7 days after CABG or CRP > 10 or t>37.0 more than 7 days after CABG).
measure: Residual myocardial ischemia.
time frame: within 30 days after CABG
description: New onset of myocardial contractility deterioration on echocardiography (with or without strain, documented hypokinetic or akinetic wall motion).
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.
intervention type: Procedure
intervention name: On-pump CABG.
description: On-pump coronary artery bypass grafting.
arm group label: On-pump CABG.
intervention type: Procedure
intervention name: Off-pump CABG.
description: Off-pump coronary artery bypass grafting.
arm group label: Off-pump CABG.
intervention type: Procedure
intervention name: Pump-assisted CABG.
description: Pump-assisted CABG.
arm group label: Pump-assisted CABG.
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Alexander Nemkov, PhD
role: Study Director
affiliation: First State Pavlov 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: Sponsor
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
sharing ipd: No
ipd description: Individual participant data are confidential.