<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/NCT04489355</url>
  </required_header>
  <id_info>
    <org_study_id>Tomsk NRMC ICM</org_study_id>
    <nct_id>NCT04489355</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Surgical Treatment of Patients With Ischemic Cardiomyopathy</brief_title>
  <official_title>Assessment of Risks and Outcomes of Surgical Intervention in Patients With Ischemic Cardiomyopathy in the Early and Long-term Postoperative Period, Selection of Optimal Surgical and Surgical Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tomsk National Research Medical Center of the Russian Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tomsk National Research Medical Center of the Russian Academy of Sciences</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 study focuses on the development of a new personalized approach to diagnostics and&#xD;
      surgical treatment of patients with ischemic cardiomyopathy. The algorithm for selection of&#xD;
      patients for certain type of cardiac surgery will be developed. The models for prediction of&#xD;
      the risks and outcomes of cardiac surgery will be elaborated to reduce the rate of&#xD;
      complications in the early and long-term postoperative period in patients with ischemic&#xD;
      cardiomyopathy. Imaging modalities, methods for assessement of structural and functional&#xD;
      state of the myocardium, biochemistry testing, immunohistochemical examination, and&#xD;
      myocardial biopsy studies will be used to achieve these goals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to develop a new personalized approach to diagnostics and surgical&#xD;
      treatment of patients with ischemic cardiomyopathy.&#xD;
&#xD;
      Research Objectives:&#xD;
&#xD;
        1. To assess the prognostic values of scintigraphic indicators of myocardial perfusion,&#xD;
           contractility, and metabolism in patients with ischemic cardiomyopathy in regard to the&#xD;
           development of cardiac remodeling and adverse cardiovascular events in the mid term&#xD;
           after surgery.&#xD;
&#xD;
        2. To assess the prognostic values of parameters of cardiac magnetic resonance imaging&#xD;
           (cMRI) allowing to predict the risks of surgical intervention and chronic heart failure&#xD;
           progression in patients with ischemic cardiomyopathy.&#xD;
&#xD;
        3. To analyze the relationships between the structural and functional state of the&#xD;
           myocardium and the effectiveness of various types of surgery in patients with ischemic&#xD;
           cardiomyopathy. The structural and functional state of the myocardium is assessed by the&#xD;
           instrumental methods including myocardial scintigraphy, cMRI, stress echocardiography,&#xD;
           spiroergometry, and intraoperative fluometry.&#xD;
&#xD;
        4. To identify the myocardial biopsy-based predictors of adverse outcome in patients with&#xD;
           ischemic cardiomyopathy in the early and mid term postoperative period in patients with&#xD;
           ischemic cardiomyopathy.&#xD;
&#xD;
        5. To study the relationships between tissue and molecular biomarkers, severity of ischemic&#xD;
           cardiomyopathy, and the outcomes in patients with ischemic cardiomyopathy in the&#xD;
           postoperative period.&#xD;
&#xD;
        6. To introduce new and to optimize existing methods of surgical treatment in patients with&#xD;
           ischemic cardiomyopathy.&#xD;
&#xD;
        7. To develop an algorithmic model for assessing the risks and predicting outcomes of&#xD;
           surgical intervention in patients with ischemic cardiomyopathy in the postoperative&#xD;
           period.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
        1. Clinical status of the patient: collection of complaints, medical history, physical&#xD;
           examination, assessment of anthropometric indicators (measurement of body weight,&#xD;
           height, BMI), and demographic indicators before and in the control period after surgical&#xD;
           treatment.&#xD;
&#xD;
        2. General clinical examination: standard 12-lead ECG, general urine analysis, general&#xD;
           blood analysis, blood chemistry, coagulation, chest x-ray, ultrasound of the carotid and&#xD;
           femoral arteries.&#xD;
&#xD;
        3. Echocardiography: determination of the type of aneurysm according to Di Donato;&#xD;
           measuring the distance between the papillary muscles of the left ventricle; assessing&#xD;
           the depth of co-optation of the mitral valve cusps; measuring Vena contracta; measuring&#xD;
           the radius of the proximal regurgitation zone, cm; Effective Regurgitant Orifice Area&#xD;
           (EROA, cm2); assessing systolic index and sphericity index. Stress echocardiography with&#xD;
           dobutamine. Before stress echocardiography on a Vivid E9 ultrasound system (GE,&#xD;
           Healthcare), continuous intravenous administration of dobutamine HEXAL, starting from 5&#xD;
           μg/kg/min and increasing its dose every 3 minutes to 10, 15, 20, 30, and 40 μg/kg.&#xD;
&#xD;
        4. Coronarography for assessing the anatomy and condition of the coronary pool using an&#xD;
           angiographic unit (Axiom Artis/Innova 2121-IQ (General Electric, USA)).&#xD;
&#xD;
        5. Contrast-enhanced cMRI to assess the following parameters:&#xD;
&#xD;
             -  mass of viable left ventricular myocardium;&#xD;
&#xD;
             -  volumes of cardiac cavities;&#xD;
&#xD;
             -  diameter of the mitral and tricuspid valve rings with the determination of&#xD;
                regurgitation degree;&#xD;
&#xD;
             -  the long axis of the ventricle;&#xD;
&#xD;
             -  left ventricular ejection fraction;&#xD;
&#xD;
             -  visualization of akinetic and hypokinetic myocardium;&#xD;
&#xD;
             -  the presence of blood clots in the cavities of the heart;&#xD;
&#xD;
        6. Six-minute walk test.&#xD;
&#xD;
        7. Spiroergometry by SCHILLER complex with a GanshornPowerCube gas analyzer.&#xD;
&#xD;
        8. Determination of the plasma and serum levels of the NT-proBNP, endothelin-1, troponin I,&#xD;
           galectin-3, ST-2, matrix metalloproteinases (MMP) 2 and 9, and C-reactive protein.&#xD;
&#xD;
        9. Evaluation of myocardial perfusion by single-photon emission computed tomography using&#xD;
           radiopharmaceuticals 199 Tl chloride or 99m Tc. Myocardial perfusion scintigraphy with&#xD;
           Tc-methoxyisobutylisonitrile (99mTc-MIBI) and iodine-123-labeled&#xD;
           iodine-123-phenylmethylmethylene diode and metabolic scintigraphy with 123I-FMPDKc.&#xD;
           Stress ventriculography with 99-Tc-pyrophosphate by GKS-301T gamma camera (VNIIMP-VITA,&#xD;
           Russia).&#xD;
&#xD;
       10. Intraoperative fluometry of coronary grafts during coronary artery bypass grafting using&#xD;
           the Medistim VeriQ System.&#xD;
&#xD;
       11. Myocardial biopsy: it is planned to take myocardial biopsy samples in patients with&#xD;
           ischemic cardiomyopathy intraoperatively. In case of aneurysmectomy, myocardial biopsy&#xD;
           will be sampled in the middle left ventricular (LV) parts of the anterior, posterior,&#xD;
           lateral walls and the endocardium, the wall of the aneurysm and the portion of the right&#xD;
           atrial appendage, the right atrial appendage in the absence of aneurysmectomy. The&#xD;
           preparation of histological samples will be carried out in a standard way: fixation of&#xD;
           biopts in formalin with further filling in a paraffin medium and staining with&#xD;
           hematoxylin and eosin with determination of morphometric indicators. For histochemical&#xD;
           reactions, biopsy samples freshly frozen in liquid nitrogen will be used. The enzymatic&#xD;
           activity of succinant dehydrogenase (LDH), lactate dehydrogenase (LDH), and&#xD;
           3-hydroxybutyrate dehydrogenase (3-HBDH) will be studied using the Lojda tetrazolium&#xD;
           method according to the intensity of staining of the structure using the ImageJ program&#xD;
           (NIH, USA).&#xD;
&#xD;
       12. Statistical processing of data:&#xD;
&#xD;
      Structured collection of patient data will be performed in a database formed on the platform&#xD;
      of the Microsoft Excel 2010 software (Microsoft Corp., USA). Statistical processing of the&#xD;
      results will be carried out using the SPSS 23.0 for Windows software package (IBM Corp.,&#xD;
      Armonk, NY, USA). The normality of the law of distribution of quantitative indicators will be&#xD;
      checked using the Shapiro-Wilks criterion. Normally distributed parameters will be presented&#xD;
      as mean value (M) and standard deviation (StD) in the form M ± StD; not normally distributed&#xD;
      parameters will be presented as median (Me) and the 1st and 3rd interquantile intervals (Q25&#xD;
      - Q75) in the form of Me [Q25; Q75]. Qualitative data will be described by the frequency of&#xD;
      occurrence or its percentage. To find statistical dependences, to determine their strength&#xD;
      and direction, the Pearson correlation coefficient (r) (for normally distributed parameters)&#xD;
      and Spearman correlation coefficient (for for not normally distributed parameters and for&#xD;
      qualitative indicators in the ordinal scale) will be calculated. Using logistic regression,&#xD;
      significant predictors will be identified for the values of reverse remodeling in the long&#xD;
      term after surgical treatment. When conducting a multivariate analysis of interconnections,&#xD;
      first, by means of a univariate analysis, the main parameters that influence the studied&#xD;
      value will be identified, then, based on the search for intergroup correlations, the signs&#xD;
      that have a moderate or strong relationship will be eliminated, and multivariate modeling of&#xD;
      the relationships will be performed.&#xD;
&#xD;
      Survival analysis will be performed using the Kaplan-Meier method. All statistics will be&#xD;
      considered significant at p &lt;0.05.&#xD;
&#xD;
      During the work, the methods of statistical analysis can be revised and (or) supplemented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 28, 2013</start_date>
  <completion_date type="Anticipated">May 1, 2024</completion_date>
  <primary_completion_date type="Actual">January 28, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with postoperative left ventricular remodeling according to echocardiography.</measure>
    <time_frame>12 months</time_frame>
    <description>Number of participants with a decrease in left ventricular end-systolic volume by 15% or more.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac death</measure>
    <time_frame>12 months</time_frame>
    <description>Cardiac death, %</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with increased exercise tolerance</measure>
    <time_frame>12 months</time_frame>
    <description>Number of participants with increased exercise tolerance according to spiroergometry by 15% or more.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Chronic Heart Failure</condition>
  <condition>Ischemic Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>CABG</arm_group_label>
    <description>The patients with ischemic cardiomyopathy underwent coronary artery bypass graft (CABG)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CABG with SVR</arm_group_label>
    <description>The patients with ischemic cardiomyopathy underwent coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CABG with mitral repair</arm_group_label>
    <description>The patients with ischemic cardiomyopathy underwent coronary artery bypass graft (CABG) with and mitral repair (MR)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CABG with SVR and mitral repair</arm_group_label>
    <description>The patients with ischemic cardiomyopathy underwent coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR) and mitral repair (MR)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR) and mitral repair (MR)</intervention_name>
    <arm_group_label>CABG</arm_group_label>
    <arm_group_label>CABG with SVR</arm_group_label>
    <arm_group_label>CABG with SVR and mitral repair</arm_group_label>
    <arm_group_label>CABG with mitral repair</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Myocardial biopsy: it is planned to intraoperatively collect myocardial biopsy samples from&#xD;
      patients with ischemic cardiomyopathy. In case of aneurysmectomy and myocardial biopsy in the&#xD;
      middle parts of the left ventricle of the anterior, posterior, lateral walls and&#xD;
      interventricular septum on the side of the endocardium, the wall of the aneurysm and the&#xD;
      portion of the right atrial appendage, in the absence of an aneurysm, only the portion of the&#xD;
      right atrial appendage.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ischemic cardiomyopathy with indications for cardiac surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  left ventricular ejection fraction less than or equal to 40%; a history of myocardial&#xD;
             infarction with a duration of more than 3 months and/or stenosis of more than 75% of&#xD;
             the trunk of the left coronary artery, or proximal stenosis of the anterior descending&#xD;
             artery and/or stenosis of more than 75% of two or more coronary arteries; final LV&#xD;
             systolic index greater than or equal to 60 ml / m2 according to echocardiography, age&#xD;
             18-70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the presence of organic heart defects of rheumatic and infectious etiology; acute&#xD;
             myocardial infarction; less than 3 months after acute coronary or cerebrovascular&#xD;
             events; severe pulmonary hypertension not associated with mitral regurgitation (above&#xD;
             75 mmHg); contraindications for operations with cardiopulmonary bypass; chronic&#xD;
             alcoholism (including alcoholic damage to the heart), mental disorders; severe course&#xD;
             of bronchial asthma, chronic obstructive pulmonary disease in the acute stage;&#xD;
             oncological diseases in the terminal stage, refusal of the patient or relatives to&#xD;
             participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vladimir M Shipulin, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Cardiology Research Institute, Tomsk NRMC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sergey L Andreev, MD, PhD</last_name>
    <phone>+79069543622</phone>
    <email>anselen@rambler.ru</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yana J Anfinogenova, PhD</last_name>
    <phone>+79095390220</phone>
    <email>anfiyj@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tomsk National Research Medical Center of the Russian Academy of Sciences</name>
      <address>
        <city>Tomsk</city>
        <zip>634012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sergey L Andreev, researcher</last_name>
      <phone>89069543622</phone>
      <email>anselen@rambler.ru</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic heart failure</keyword>
  <keyword>Ischemic cardiomyopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.</ipd_time_frame>
    <ipd_access_criteria>Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.</ipd_access_criteria>
  </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/NCT04489355
org study id: Tomsk NRMC ICM
nct id: NCT04489355
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study focuses on the development of a new personalized approach to diagnostics and
      surgical treatment of patients with ischemic cardiomyopathy. The algorithm for selection of
      patients for certain type of cardiac surgery will be developed. The models for prediction of
      the risks and outcomes of cardiac surgery will be elaborated to reduce the rate of
      complications in the early and long-term postoperative period in patients with ischemic
      cardiomyopathy. Imaging modalities, methods for assessement of structural and functional
      state of the myocardium, biochemistry testing, immunohistochemical examination, and
      myocardial biopsy studies will be used to achieve these goals.
The aim of the study is to develop a new personalized approach to diagnostics and surgical
      treatment of patients with ischemic cardiomyopathy.

      Research Objectives:

        1. To assess the prognostic values of scintigraphic indicators of myocardial perfusion,
           contractility, and metabolism in patients with ischemic cardiomyopathy in regard to the
           development of cardiac remodeling and adverse cardiovascular events in the mid term
           after surgery.

        2. To assess the prognostic values of parameters of cardiac magnetic resonance imaging
           (cMRI) allowing to predict the risks of surgical intervention and chronic heart failure
           progression in patients with ischemic cardiomyopathy.

        3. To analyze the relationships between the structural and functional state of the
           myocardium and the effectiveness of various types of surgery in patients with ischemic
           cardiomyopathy. The structural and functional state of the myocardium is assessed by the
           instrumental methods including myocardial scintigraphy, cMRI, stress echocardiography,
           spiroergometry, and intraoperative fluometry.

        4. To identify the myocardial biopsy-based predictors of adverse outcome in patients with
           ischemic cardiomyopathy in the early and mid term postoperative period in patients with
           ischemic cardiomyopathy.

        5. To study the relationships between tissue and molecular biomarkers, severity of ischemic
           cardiomyopathy, and the outcomes in patients with ischemic cardiomyopathy in the
           postoperative period.

        6. To introduce new and to optimize existing methods of surgical treatment in patients with
           ischemic cardiomyopathy.

        7. To develop an algorithmic model for assessing the risks and predicting outcomes of
           surgical intervention in patients with ischemic cardiomyopathy in the postoperative
           period.

      Methods:

        1. Clinical status of the patient: collection of complaints, medical history, physical
           examination, assessment of anthropometric indicators (measurement of body weight,
           height, BMI), and demographic indicators before and in the control period after surgical
           treatment.

        2. General clinical examination: standard 12-lead ECG, general urine analysis, general
           blood analysis, blood chemistry, coagulation, chest x-ray, ultrasound of the carotid and
           femoral arteries.

        3. Echocardiography: determination of the type of aneurysm according to Di Donato;
           measuring the distance between the papillary muscles of the left ventricle; assessing
           the depth of co-optation of the mitral valve cusps; measuring Vena contracta; measuring
           the radius of the proximal regurgitation zone, cm; Effective Regurgitant Orifice Area
           (EROA, cm2); assessing systolic index and sphericity index. Stress echocardiography with
           dobutamine. Before stress echocardiography on a Vivid E9 ultrasound system (GE,
           Healthcare), continuous intravenous administration of dobutamine HEXAL, starting from 5
           μg/kg/min and increasing its dose every 3 minutes to 10, 15, 20, 30, and 40 μg/kg.

        4. Coronarography for assessing the anatomy and condition of the coronary pool using an
           angiographic unit (Axiom Artis/Innova 2121-IQ (General Electric, USA)).

        5. Contrast-enhanced cMRI to assess the following parameters:

             -  mass of viable left ventricular myocardium;

             -  volumes of cardiac cavities;

             -  diameter of the mitral and tricuspid valve rings with the determination of
                regurgitation degree;

             -  the long axis of the ventricle;

             -  left ventricular ejection fraction;

             -  visualization of akinetic and hypokinetic myocardium;

             -  the presence of blood clots in the cavities of the heart;

        6. Six-minute walk test.

        7. Spiroergometry by SCHILLER complex with a GanshornPowerCube gas analyzer.

        8. Determination of the plasma and serum levels of the NT-proBNP, endothelin-1, troponin I,
           galectin-3, ST-2, matrix metalloproteinases (MMP) 2 and 9, and C-reactive protein.

        9. Evaluation of myocardial perfusion by single-photon emission computed tomography using
           radiopharmaceuticals 199 Tl chloride or 99m Tc. Myocardial perfusion scintigraphy with
           Tc-methoxyisobutylisonitrile (99mTc-MIBI) and iodine-123-labeled
           iodine-123-phenylmethylmethylene diode and metabolic scintigraphy with 123I-FMPDKc.
           Stress ventriculography with 99-Tc-pyrophosphate by GKS-301T gamma camera (VNIIMP-VITA,
           Russia).

       10. Intraoperative fluometry of coronary grafts during coronary artery bypass grafting using
           the Medistim VeriQ System.

       11. Myocardial biopsy: it is planned to take myocardial biopsy samples in patients with
           ischemic cardiomyopathy intraoperatively. In case of aneurysmectomy, myocardial biopsy
           will be sampled in the middle left ventricular (LV) parts of the anterior, posterior,
           lateral walls and the endocardium, the wall of the aneurysm and the portion of the right
           atrial appendage, the right atrial appendage in the absence of aneurysmectomy. The
           preparation of histological samples will be carried out in a standard way: fixation of
           biopts in formalin with further filling in a paraffin medium and staining with
           hematoxylin and eosin with determination of morphometric indicators. For histochemical
           reactions, biopsy samples freshly frozen in liquid nitrogen will be used. The enzymatic
           activity of succinant dehydrogenase (LDH), lactate dehydrogenase (LDH), and
           3-hydroxybutyrate dehydrogenase (3-HBDH) will be studied using the Lojda tetrazolium
           method according to the intensity of staining of the structure using the ImageJ program
           (NIH, USA).

       12. Statistical processing of data:

      Structured collection of patient data will be performed in a database formed on the platform
      of the Microsoft Excel 2010 software (Microsoft Corp., USA). Statistical processing of the
      results will be carried out using the SPSS 23.0 for Windows software package (IBM Corp.,
      Armonk, NY, USA). The normality of the law of distribution of quantitative indicators will be
      checked using the Shapiro-Wilks criterion. Normally distributed parameters will be presented
      as mean value (M) and standard deviation (StD) in the form M ± StD; not normally distributed
      parameters will be presented as median (Me) and the 1st and 3rd interquantile intervals (Q25
      - Q75) in the form of Me [Q25; Q75]. Qualitative data will be described by the frequency of
      occurrence or its percentage. To find statistical dependences, to determine their strength
      and direction, the Pearson correlation coefficient (r) (for normally distributed parameters)
      and Spearman correlation coefficient (for for not normally distributed parameters and for
      qualitative indicators in the ordinal scale) will be calculated. Using logistic regression,
      significant predictors will be identified for the values of reverse remodeling in the long
      term after surgical treatment. When conducting a multivariate analysis of interconnections,
      first, by means of a univariate analysis, the main parameters that influence the studied
      value will be identified, then, based on the search for intergroup correlations, the signs
      that have a moderate or strong relationship will be eliminated, and multivariate modeling of
      the relationships will be performed.

      Survival analysis will be performed using the Kaplan-Meier method. All statistics will be
      considered significant at p <0.05.

      During the work, the methods of statistical analysis can be revised and (or) supplemented.
observational model: Other
time perspective: Prospective
measure: Number of participants with postoperative left ventricular remodeling according to echocardiography.
time frame: 12 months
description: Number of participants with a decrease in left ventricular end-systolic volume by 15% or more.
measure: Cardiac death
time frame: 12 months
description: Cardiac death, %
measure: Number of participants with increased exercise tolerance
time frame: 12 months
description: Number of participants with increased exercise tolerance according to spiroergometry by 15% or more.
arm group label: CABG
description: The patients with ischemic cardiomyopathy underwent coronary artery bypass graft (CABG)
arm group label: CABG with SVR
description: The patients with ischemic cardiomyopathy underwent coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR)
arm group label: CABG with mitral repair
description: The patients with ischemic cardiomyopathy underwent coronary artery bypass graft (CABG) with and mitral repair (MR)
arm group label: CABG with SVR and mitral repair
description: The patients with ischemic cardiomyopathy underwent coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR) and mitral repair (MR)
intervention type: Procedure
intervention name: coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR) and mitral repair (MR)
arm group label: CABG
arm group label: CABG with SVR
arm group label: CABG with SVR and mitral repair
arm group label: CABG with mitral repair
Myocardial biopsy: it is planned to intraoperatively collect myocardial biopsy samples from
      patients with ischemic cardiomyopathy. In case of aneurysmectomy and myocardial biopsy in the
      middle parts of the left ventricle of the anterior, posterior, lateral walls and
      interventricular septum on the side of the endocardium, the wall of the aneurysm and the
      portion of the right atrial appendage, in the absence of an aneurysm, only the portion of the
      right atrial appendage.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Vladimir M Shipulin, MD, PhD
role: Study Chair
affiliation: Cardiology Research Institute, Tomsk NRMC
last name: Sergey L Andreev, MD, PhD
phone: +79069543622
email: anselen@rambler.ru
last name: Yana J Anfinogenova, PhD
phone: +79095390220
email: anfiyj@gmail.com
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Cardiovascular Diseases
mesh term: Cardiomyopathies
mesh term: Ischemia
sharing ipd: Yes
ipd description: Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
ipd access criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.