Autologous Bone Marrow Mononuclear Cells in the Combined Treatment of Coronary Heart Disease
Condition: Ischemic Heart Disease; Bone Marrow Cells; Coronary Artery Bypass Grafting (CABG); Heart Failure, Diastolic
MeSH terms: Heart Failure; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Heart Failure, Diastolic
Study type: Interventional

Summary: 
      The purpose of this study evaluate the effect of the method of administration of autologous
      bone marrow mononuclear cells for the duration of of functioning aorto-coronary bypass grafts
      in the surgical treatment of coronary heart disease, to assess the degree of effectiveness
      depending on the method of transplantation (intramyocardial, intracoronary, combined).
    

Detailed description: 
      Additional estimation of safety:

        1. Assessment of EuroScore II.

        2. Hospital Stay.

        3. The duration of stay in the intensive care unit.

        4. Restoration of cardiac rhythm at the end of the main stage of operation (defibrillation/
           self-recovery).

        5. The time of extracorporeal circulation.

        6. Time of anoxia.

        7. Volume abjointed (drainage) postoperative day 1, day 3

        8. Troponin I, CPK-MB, Myoglobin at 1, 3 postoperative days.

        9. Hb/ HCT/K+ at the end of cardiopulmonary bypass (CPB) and Hb/ HCT/K+/ ABC at the end of
           the operation.

       10. Assessment of the degree of manifestation of a systemic inflammatory reaction in the
           postoperative period - leukocytes (Leu), CRP

       11. Postoperative complications (hydrothorax, hydropericardium, arrhythmias, resternotomy).

       12. Echocardiography at 7-14 days after surgery.

      Estimation of efficiency:

        1. Evaluation of systolic and diastolic myocardial function. Assessment of myocardial
           perfusion and metabolism (before and after treatment) - Speckle tracking
           echocardiography.

        2. Patency of grafts within a specified time of treatment (angiography).

        3. Dependence and duration of positive clinical effect on the amount of injected cell
           material.

        4. Evaluation of the quality of life (Minnesota questionnaire, Seattle questionnaire, SF-
           36 questionnaire).

        5. All-cause Mortality Associated With the Progression of Basic

        6. Disease.Dynamics of the functional class of angina.

        7. Dynamics of the functional class of heart failure.

        8. Dynamics of test data with a 6-minute walk.

      Predicting the results of treatment (the effect of a number of parameters):

        1. Age.

        2. Gender.

        3. The body mass index.

        4. Diabetes.

        5. Smoking.

        6. Family history of cardiovascular events.

        7. Duration of ischemic heart disease.

        8. Serum total cholesterol (+ fractions).

        9. Leukocytosis and CRP level (initial level and rate of decrease in the postoperative
           period).

       10. The level of creatinine.

       11. The presence / absence of extracardiac arteriopathy.

       12. The intramyocardial or intracoronary injection of BM-MNCs.

       13. Assessment of the bone marrow: the number of nucleated cells, CD34 +, CD133 +.
    

Intervention name(s): Group 1; Group 0; Group 2
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Coronary artery bypass grafting with intramyocardial administration of autologous bone marrow mononuclear cells 0.2 ml - 10 injection in the zone of blood supply LAD.; Coronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.; Coronary artery bypass grafting with intramyocardial and intracoronary administration of autologous bone marrow mononuclear cells intramyocardial administration 0.2 ml - 10 injection in the zone of blood supply LAD.
Other intervention name(s): CABG with intramyocardial administration of ABMMC.; CABG with administration of 0.9 % sodium chlorid.; CABG with intramyocardial and intracoronary administration of ABMMC.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Potential participants in this study were all patients admitted for planned coronary artery bypass grafting under extracorporeal circulation and who, according to angiographic examination, had 3 or more stenotic coronary arteries. The final decision on the inclusion of each individual patient in this study was determined taking into account the inclusion criteria. The study was conducted according to the approved protocol as a randomized, blind, placebo controlled.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: ischemic heart disease; bone marrow cells; coronary artery bypass grafting (CABG); reperfusion injury; myocardial dysfunction, diastolic; Heart Failure, Diastolic; transplantation of autologous mononuclear cells; intramyocardial administration; intracoronary administration