Bone Marrow Cells, Coronary Artery Bypass Grafting (CABG), Heart Failure, Diastolic, Ischemic Heart Disease
Conditions
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
Brief 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 +.
Interventions
PROCEDUREGroup 1
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.
PROCEDUREGroup 0
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.
PROCEDUREGroup 2
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.
Sponsors
St. Petersburg State Pavlov Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Randomization into three observation groups was carried out according to the table of random numbers.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men and women from 18 to 80 years * Patients with angina pectoris III-IV functional class * According to angiographic examination, the presence of 3 or more stenotic coronary arteries * Aorto-coronary bypass surgery under cardiopulmonary bypass * Patients signed informed consent
Exclusion criteria
* Intolerance of heparin and HES. * Hypothyroidism and hyperthyroidism. * Associated pathology with a projected lifespan limitation to 3 years. * infection diseases * Simultaneous participation in another study. * Pregnancy. * Severe mental disorder. * Refusal of a patient to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restoration of the Heart Rate After the Completion of the Main Stage of the Surgical Intervention. Additional Estimation of Safety. | Upon completion of the main stage of surgery. | The need to perform defibrillation to restore sinus rhythm, at the end of the main stage of surgery. |
| Assessment of the Initial Risk of Surgery (EuroScore II). | Before CABG surgery at baseline. | EuroScoreII is intended to assess the risk of adverse outcome of coronary artery bypass grafting. Assessment factors: age, sex, serum creatinine, extracardiac artery disease, chronic lung disease, severe neurological disorders, previous cardiac surgery, previous myocardial infarction, left ventricular dysfunction, diabetes mellitus, pulmonary hypertension, IV class of angina severity, active endocarditis, unstable angina, surgery, critical condition of the patient before surgery, type of surgery. The higher the percentage, the higher the risk of surgery. |
| Length of Hospital Stay. Length of Stay in the Intensive Care Unit. | Primary hospitalization for planned CABG. | The results were obtained from the analysis of primary data. |
| The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | The parameters were evaluated initially at baseline in the postoperative period - an interval of 0-6 hours, 12-18 hours, 18-24 hours, 48 hours, 72 hours, 96 hours, 7 days and 14 days. | Assessment of the severity of the systemic inflammatory response during hospital stay after surgery. Assessment of the level of inflammation by the severity of an increase in leukocytes (leukocytosis). Leukocytosis - an increase in the number of leukocytes per unit volume of blood. The norm of leukocytes in the blood is 5.5-8.810\^9 /l. For adults, leukocytosis is considered to be an increase in the number of leukocytes in the blood of more than 9.0\*10\^9 / l In the statistical analysis, the grouping of indicators in the indicated intervals was used, in view of the individual characteristics of the course of the postoperative period in each case. |
| Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), | Initial data, control point in the interval 4-6 days of the postoperative period, control point in the interval 12-14 days of the postoperative period. | Results of dynamic control of laboratory parameters of CRP. C-reactive protein. This fraction of plasma proteins increases in the presence of an inflammatory process in the body. It is synthesized in response to the ingestion of toxins of pathological microorganisms into the bloodstream and neutralizes them by binding them. In addition, it appears when the body's own cells are destroyed in the event of necrosis, tumor disintegration or extensive trauma, inactivating the resulting products. In addition to eliminating toxins, CRP triggers a cascade of immune responses aimed at eliminating pathologically altered structures. Normally absent (or less than 0.4 mg / l). In the statistical analysis, the grouping of indicators in the indicated intervals was used, in view of the individual characteristics of the course of the postoperative period in each case. |
| The Volume of Discharge Through the Drains in the Early Postoperative Period. | Evaluation of these data - for the time spent in the intensive care unit before removing the drains. | A daily assessment of the discharge by drainage before removal was carried out. It was carried out to assess the possible development of an excessive inflammatory reaction (polyserositis phenomena) in response to the transplantation of autologous bone marrow mononuclear cells. |
| Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | 1 and 3 days of the postoperative period. | Assessment of the severity of the period of ischemia / reperfusion. And the effect of autologous bone marrow mononuclear cells transplantation on these indicators. |
| Dynamics of Markers of Myocardial Damage (Creatine Phosphokinase Fraction MB (CPK-MB)). | 1 and 3 days of the postoperative period. | Assessment of the severity of the period of ischemia / reperfusion. And the effect of autologous bone marrow mononuclear cells transplantation on these indicators. |
| Intraoperative Assessment of Homeostasis (Hemoglobin (Hb). | Intraoperative data. | These parameters were evaluated at the end of the cardiopulmonary bypass and at the end of the surgery. The interval between indicators is on average from 60 to 120 minutes. |
| Intraoperative Assessment of Homeostasis (Hematocrit (HCT)). | Intraoperative data. | These parameters were evaluated at the end of the cardiopulmonary bypass and at the end of the surgery. The interval between indicators is on average from 60 to 120 minutes. |
| Intraoperative Assessment of Homeostasis (К+). | Intraoperative data. | These parameters were evaluated at the end of the cardiopulmonary bypass and at the end of the surgery. The interval between indicators is on average from 60 to 120 minutes. |
| Cardiopulmonary Bypass Time. | Intraoperative data. | — |
| Time of Aortic Clamping (Anoxia). | Intraoperative data. | Estimation of the time from the moment the clamp is applied to the aorta (complete clamping of the aorta) to the removal of the clamp from the aorta. |
| Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Postoperative period. | The presence of complications in the postoperative period (Hydrothorax, Hydropericardium, Cardiac arrhythmias - atrial fibrillation / atrial flutter). |
| Left Ventricular Ejection Fraction - Echocardiography - Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. | 7-14 days of the postoperative period | Evaluation of myocardial contractility according to echocardiography, in particular the left ventricular ejection fraction, was carried out within 7-14 days of the postoperative period, depending on the patient's clinical condition, as well as the maximum degree of information content of this study. The lower the indicator, the worse the prognosis of an unfavorable outcome. |
| Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. | 7-14 days after surgery | Assessment of myocardial contractility according to echocardiography, in particular the size of the left ventricle - its index, was carried out within 7-14 days of the postoperative period, depending on the clinical condition of the patient, as well as on the maximum information content of this study. The higher the indicator (left ventricular size - index), the worse the prognosis of an unfavorable outcome. The index is used as an indicator of payment to obtain a more reliable result (taking into account the individual characteristics of each patient). index - left ventricular size (mm.)/ body mass index (kg/m\^2). |
| Volume of the Left Ventricle - Index - Echocardiography. Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. | 7-14 days after surgery | Evaluation of myocardial contractility according to echocardiography, in particular volume of the left ventricle - index was carried out within 7-14 days of the postoperative period, depending on the patient's clinical condition, as well as the maximum degree of information content of this study. The greater the figure (volume of the left ventricle - index), the worse the prognosis of adverse outcome. The index is used as an indicator of the payment to obtain a more reliable result (taking into account individual characteristics of each patient). index - volume of the left ventricle (ml.)/ body mass index (kg / m\^2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). | up to 12 months | According to the angiographic study. |
| Analysis of the Effect of Left Ventricular Diastolic Dysfunction on the Patency of the Grafts. | up to 12 months | Echocardiographic data. |
| All-cause Mortality Associated With the Progression of Basic Disease. | 12 months after surgery | The total number of deaths - in the primary hospitalization and during the observation period of 12 months after surgical treatment - deaths associated with the progression of the initial disease. The complication rate for CABG operations is 30±10%. According to n1=kn2; n1 sample size, in the control. In group 0, k=2/3 times more than in group 1 and group 2. The difference between the test and control frequencies is ε=p1-p2. Accordingly, with p1 = 0.2; p2=0.4, δ= 0.1; n1=49.5, n2=33. The result is group 0 - 36, group 1 and 2 - 25+25 = 50. The null hypothesis of complication rate δ.All patients included in the study. |
| Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | At baseline and after one year. | The SF-36 questionnaire. The indicators of each scale vary between 0 and 100, where 100 represents total health. The results are presented in the form of scores on 8 scales, compiled in such a way that a higher score indicates a higher level of quality of life.MHFLQ - for patients with heart failure.The specified questionnaire consists of 21 questions. To answer each question, a scale of 6 points from the minimum intensity of certain symptoms to the maximum is used. The assessment is based on the sum of points, where the maximum number of points - 105 corresponds to the patient's worst condition. The lowest score 0 points is the best clinical condition of the patient. SAQ consists of 19 questions about the patient's condition, which are divided into the following 5 scales. The quality of life for each of the five scales under consideration is measured in percent, with 0% corresponding to the worst quality of life, and 100% to the best. |
| Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | up to 12 months | 1. functional class - The usual load does not cause changes in the state of health. Painful attacks occur against the background of excessive loads - after climbing several flights of stairs, while walking fast. 2. functional class - Pain attacks when walking more than 500 meters, when climbing stairs more than one floor. 3. functional class - The patient does not tolerate minimal physical activity. An attack occurs when walking a distance of 50-100 meters. Climbing stairs is difficult. 4. functional class - Activity is significantly limited. Angina pectoris manifests itself when performing minimal actions, including at rest. |
| Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. | Assessment of the dynamics at 12 months after treatment. | 1. functional class - There is no limitation of a person's physical activity, shortness of breath manifests itself when going above the third floor. 2. functional class - slight limitation of activity, palpitations, shortness of breath, fatigue occur during normal physical activity and more. 3. functional class - Symptoms occur with the smallest physical activity, resulting in a significant decrease in activity. At rest, clinical manifestations are not observed. The smaller the functional class, the better the quality of human life. |
| Evaluation of the Left Ventricular Ejection Fraction 12 Months After Treatment. | 12 months after treatment. | According to echocardiography. |
| Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | 12 months after the treatment. | Evaluation of myocardial contractility according to echocardiography, in particular the size of the left ventricle - the index was carried out 12 months after CABG. The higher the indicator (left ventricular size - index), the worse the prognosis of an unfavorable outcome. The index is used as an indicator of the payment to obtain a more reliable result (taking into account individual characteristics of each patient). index - size of the left ventricle (mm.)/ body mass index (kg/m\^2). |
| Estimation of the Index of Volumetric Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | 12 Months After the Treatment | Evaluation of myocardial contractility according to echocardiography, in particular the volume of the left ventricle - the index was carried out 12 months after CABG. The higher the indicator (left ventricular volume - index), the worse the prognosis of an unfavorable outcome. The index is used as an indicator of the payment to obtain a more reliable result (taking into account individual characteristics of each patient). index - volume of the left ventricle (mm.)/ body mass index (kg/m\^2). |
| Assessment of Left Ventricular Diastolic Function - Peak E of Transmitral Flow and Peak А of Transmitral Flow 12 Months After Treatment. | 12 months after treatment. | Evaluation of left ventricular diastolic function (echocardiography). The peak velocity E reflects the pressure gradient between the LA and LV in early diastole, and it is affected by preload and disturbance LV relaxation The speed of peak A, which forms at the end diastole, influences LV compliance and contractility left atrium. |
| Assessment of Left Ventricular Diastolic Function E/A - 12 Months After Treatment. | 12 months after treatment | The ratio of the transmitral flow, wave E (ejection wave / left ventricular contraction) to wave A (ejection wave / left atrial contraction). The norm is 0.75-1.5 Less than 0.75 violation of relaxation, more than 1.5 restrictive type of diastolic dysfunction. |
| Assessment of Left Ventricular Diastolic Function - DT and IVRT 12 Months After Treatment. | 12 Months After Treatment. | Echocardiographic data ( DT (Half-time of wave E), time of isovolumic relaxation of the left ventricle (IVRT). DT (Half-time of wave E). The DT time index reflects the relaxation process LV, LV diastolic pressure after mitral valve opening, and LV compliance. 150-200 ms - normal; \> 200 ms - violation of relaxation; 150-200 ms - pseudonormal type of left ventricular filling; \<150 ms - restrictive type of diastolic dysfunction IVRT (time of isovolumic relaxation of the left ventricl.) \<100 ms - normal; \> 100 ms - violation of relaxation |
| Distance Traveled in the 6-minute Walk Test. Test Results With 6 Minute Walk | initially and after 12 months | The dynamic of the number of meters walked according to the 6-minutes walk test (6MWD) in the observation groups. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Amount of Cell Material (Percentage). | Initial data at the time of collection of bone marrow cells. | Dependence and duration of positive clinical effect on the amount of injected cell material (Mononuclear fraction %, CD34+ %, CD133+ %). Assessment - mononuclear fraction, CD 34 +, CD 133+ according to flow cytometry data. |
| Smoking as a Factor That Negatively Affects the Results of the Test With a 6-minute Walk in Dynamics. | 12 months after treatment. | The distance covered (in meters) was compared with the proper value depending on age (years), height (cm), weight (kg), body mass index (BMI). The due values (6MWD (i)) were calculated using the following formulas: For men: 6МWD (i) = 7.57 × height - 5.02 × age - 1.76 × weight - 309 or 6MWD (i) = 1140 - 5.61 × BMI - 6.94 × age. For women: 6МWD (i) = 2.11 × height - 2.29 × weight - 5.78 × age + 667 Or 6МWD (i) = 1017 - 6.24 × BMI - 5.83 × age. This difference at baseline is reported as distance walked for smokers minus non-smokers. |
| The Volume of Cellular Material (Cytosis). | Initial data at the time of collection of bone marrow cells. | Dependence and Duration of Positive Clinical Effect on the Amount of Injected Cell Material (cytosis). |
Countries
Russia
Participant flow
Recruitment details
Potential participants in the study were all patients referred to the clinic for surgical treatment of coronary artery disease.
Pre-assignment details
The study included patients admitted for routine coronary artery bypass grafting under cardiopulmonary bypass, and having, according to the angiographic studies, 3 or more of stenosed coronary arteries. Patients met the inclusion criteria and signed an informed voluntary consent.
Participants by arm
| Arm | Count |
|---|---|
| Intramyocardial Administration 0.9 % NaCl (Sodium Chloride) - Group 0 Сoronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD. | 37 |
| Intramyocardial Administration Autologous Bone Marrow Stem Cells - Group 1 Сoronary artery bypass grafting with intramyocardial administration of autologous bone marrow mononuclear cells 0.2 ml - 10 injection in the zone of blood supply LAD. | 25 |
| Intramyocardial and Intracoronary Administration Autologous Bone Marrow Stem Cells - Group 2 Сoronary artery bypass grafting with intramyocardial ( 0.2 ml - 10 injection in the zone of blood supply LAD) and intracoronary administration of autologous bone marrow mononuclear cells. | 23 |
| Total | 85 |
Baseline characteristics
| Characteristic | Total | Intramyocardial and Intracoronary Administration Autologous Bone Marrow Stem Cells - Group 2 | Intramyocardial Administration Autologous Bone Marrow Stem Cells - Group 1 | Intramyocardial Administration 0.9 % NaCl (Sodium Chloride) - Group 0 |
|---|---|---|---|---|
| Acute myocardial infarction transferred in history (number). 1 acute myocardial infarctions | 40 Participants | 9 Participants | 17 Participants | 14 Participants |
| Acute myocardial infarction transferred in history (number). 2 acute myocardial infarctions | 13 Participants | 6 Participants | 3 Participants | 4 Participants |
| Acute myocardial infarction transferred in history (number). 3 acute myocardial infarctions | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 3 Participants | 7 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 20 Participants | 18 Participants | 29 Participants |
| Age, Continuous | 60.9 years STANDARD_DEVIATION 6.96 | 59.5 years STANDARD_DEVIATION 5.4 | 61.7 years STANDARD_DEVIATION 6.8 | 61 years STANDARD_DEVIATION 8 |
| Angina pectoris (functional class). 2 functional class | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Angina pectoris (functional class). 3 functional class | 76 Participants | 21 Participants | 23 Participants | 32 Participants |
| Angina pectoris (functional class). 4 functional class | 6 Participants | 1 Participants | 2 Participants | 3 Participants |
| Angina pectoris (functional class). painless ischemia | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Angiotensin converting enzyme inhibitors. | 43 Participants | 16 Participants | 9 Participants | 18 Participants |
| Angiotensin receptor antagonists. | 12 Participants | 4 Participants | 3 Participants | 5 Participants |
| Antagonists СА - calcium tubules antagonists. | 15 Participants | 4 Participants | 6 Participants | 5 Participants |
| Anticoagulants. | 8 Participants | 2 Participants | 0 Participants | 6 Participants |
| Antiplatelet agents. | 39 Participants | 9 Participants | 12 Participants | 18 Participants |
| Arterial hypertension (degree) 1 degree | 16 Participants | 5 Participants | 5 Participants | 6 Participants |
| Arterial hypertension (degree) 2 degree | 32 Participants | 7 Participants | 11 Participants | 14 Participants |
| Arterial hypertension (degree) 3 degree | 30 Participants | 9 Participants | 6 Participants | 15 Participants |
| Arterial hypertension (degree) No | 7 Participants | 2 Participants | 3 Participants | 2 Participants |
| Atherogenic coefficient. | 4.08 ratio STANDARD_DEVIATION 2.1 | 4.5 ratio STANDARD_DEVIATION 5.2 | 3.27 ratio STANDARD_DEVIATION 1.9 | 4.07 ratio STANDARD_DEVIATION 1.32 |
| BMI | 28.3 kg/m^2 STANDARD_DEVIATION 3.4 | 28.09 kg/m^2 STANDARD_DEVIATION 3.57 | 28.05 kg/m^2 STANDARD_DEVIATION 4.46 | 28.6 kg/m^2 STANDARD_DEVIATION 3.59 |
| C-reactive protein (mg/l). | 4.9 mg/l STANDARD_DEVIATION 6.8 | 5.3 mg/l STANDARD_DEVIATION 5.38 | 2.56 mg/l STANDARD_DEVIATION 1.96 | 5.9 mg/l STANDARD_DEVIATION 11.07 |
| Creatinine (mmol / l). | 0.09 mmol/l STANDARD_DEVIATION 0.02 | 0.08 mmol/l STANDARD_DEVIATION 0.02 | 0.09 mmol/l STANDARD_DEVIATION 0.02 | 0.09 mmol/l STANDARD_DEVIATION 0.02 |
| Debut of ischemic heart disease. Debut of ischemic heart disease 6-10 years | 20 Participants | 8 Participants | 4 Participants | 8 Participants |
| Debut of ischemic heart disease. Debut of ischemic heart disease over 10 years | 14 Participants | 3 Participants | 5 Participants | 6 Participants |
| Debut of ischemic heart disease. Debut of ischemic heart disease up to 5 years | 51 Participants | 12 Participants | 16 Participants | 23 Participants |
| Debut of ischemic heart disease (months). | 69.3 months STANDARD_DEVIATION 60.3 | 76.9 months STANDARD_DEVIATION 59.4 | 62.9 months STANDARD_DEVIATION 79.2 | 71.9 months STANDARD_DEVIATION 70.9 |
| Diabetes | 15 Participants | 4 Participants | 5 Participants | 6 Participants |
| Diuretics. | 18 Participants | 3 Participants | 10 Participants | 5 Participants |
| Echocardiography - 10. Tricuspid regurgitation. 1 degreeTricuspid regurgitation | 19 participants | 4 participants | 3 participants | 12 participants |
| Echocardiography - 10. Tricuspid regurgitation. 2 degreeTricuspid regurgitation | 0 participants | 0 participants | 0 participants | 0 participants |
| Echocardiography - 10. Tricuspid regurgitation. 3 degreeTricuspid regurgitation | 0 participants | 0 participants | 0 participants | 0 participants |
| Echocardiography - 10. Tricuspid regurgitation. Not | 66 participants | 19 participants | 22 participants | 25 participants |
| Echocardiography - 11. Aortic regurgitation. 1 degree Aortic regurgitation. | 14 participants | 1 participants | 2 participants | 11 participants |
| Echocardiography - 11. Aortic regurgitation. 2 degree Aortic regurgitation. | 1 participants | 0 participants | 0 participants | 1 participants |
| Echocardiography - 11. Aortic regurgitation. 3 degree Aortic regurgitation. | 0 participants | 0 participants | 0 participants | 0 participants |
| Echocardiography - 11. Aortic regurgitation. Not | 70 participants | 22 participants | 23 participants | 25 participants |
| Echocardiography - 12. Signs of myocardial remodeling. Change in local kinetics. Not | 39 Participants | 11 Participants | 14 Participants | 14 Participants |
| Echocardiography - 12. Signs of myocardial remodeling. Change in local kinetics. Yes | 46 Participants | 12 Participants | 11 Participants | 23 Participants |
| Echocardiography - 12. Signs of myocardial remodeling. Left ventricular aneurysm. Not | 76 Participants | 20 Participants | 21 Participants | 35 Participants |
| Echocardiography - 12. Signs of myocardial remodeling. Left ventricular aneurysm. Yes | 9 Participants | 3 Participants | 4 Participants | 2 Participants |
| Echocardiography - 12. Signs of myocardial remodeling. Left ventricular diastolic function/ Not | 33 Participants | 7 Participants | 8 Participants | 18 Participants |
| Echocardiography - 12. Signs of myocardial remodeling. Left ventricular diastolic function/ Yes | 52 Participants | 16 Participants | 17 Participants | 19 Participants |
| Echocardiography - 1. Lvd ind. Lvs ind. LAind. LAind. | 2.2 mm/ m^2 STANDARD_DEVIATION 0.27 | 2.1 mm/ m^2 STANDARD_DEVIATION 0.2 | 2.2 mm/ m^2 STANDARD_DEVIATION 0.3 | 2.1 mm/ m^2 STANDARD_DEVIATION 0.3 |
| Echocardiography - 1. Lvd ind. Lvs ind. LAind. Lvd ind. | 2.8 mm/ m^2 STANDARD_DEVIATION 0.36 | 2.8 mm/ m^2 STANDARD_DEVIATION 0.2 | 2.98 mm/ m^2 STANDARD_DEVIATION 0.5 | 2.7 mm/ m^2 STANDARD_DEVIATION 0.39 |
| Echocardiography - 1. Lvd ind. Lvs ind. LAind. Lvs ind. | 1.9 mm/ m^2 STANDARD_DEVIATION 0.44 | 1.9 mm/ m^2 STANDARD_DEVIATION 0.4 | 2.1 mm/ m^2 STANDARD_DEVIATION 0.5 | 1.8 mm/ m^2 STANDARD_DEVIATION 0.42 |
| Echocardiography - 2. LVEDV MOD BP ind. LVESV MOD BP ind. LVEDV MOD BP ind. | 62.7 ml/ m^2 STANDARD_DEVIATION 28.9 | 73.2 ml/ m^2 STANDARD_DEVIATION 29.9 | 73 ml/ m^2 STANDARD_DEVIATION 36.1 | 62.4 ml/ m^2 STANDARD_DEVIATION 20.7 |
| Echocardiography - 2. LVEDV MOD BP ind. LVESV MOD BP ind. LVESV MOD BP ind. | 27.9 ml/ m^2 STANDARD_DEVIATION 21.7 | 31.9 ml/ m^2 STANDARD_DEVIATION 22.3 | 32.4 ml/ m^2 STANDARD_DEVIATION 27.9 | 23.6 ml/ m^2 STANDARD_DEVIATION 14.8 |
| Echocardiography - 3. LVEF (Simpson) - left ventricular ejection fraction. | 59.8 percent STANDARD_DEVIATION 9.6 | 59.3 percent STANDARD_DEVIATION 11.1 | 56.6 percent STANDARD_DEVIATION 10.2 | 62.1 percent STANDARD_DEVIATION 7.4 |
| Echocardiography - 4. Left ventricular diastolic function - 1. Peak A of transmitral flow | 0.7 m/sec STANDARD_DEVIATION 0.2 | 0.7 m/sec STANDARD_DEVIATION 0.2 | 0.8 m/sec STANDARD_DEVIATION 0.2 | 0.8 m/sec STANDARD_DEVIATION 0.2 |
| Echocardiography - 4. Left ventricular diastolic function - 1. Peak E of transmitral flow | 0.7 m/sec STANDARD_DEVIATION 0.2 | 0.7 m/sec STANDARD_DEVIATION 0.2 | 0.6 m/sec STANDARD_DEVIATION 0.1 | 0.7 m/sec STANDARD_DEVIATION 0.2 |
| Echocardiography - 5. Left ventricular diastolic function - 2 (E/A). | 0.9 ratio STANDARD_DEVIATION 0.47 | 0.9 ratio STANDARD_DEVIATION 0.5 | 0.9 ratio STANDARD_DEVIATION 0.5 | 0.9 ratio STANDARD_DEVIATION 0.4 |
| Echocardiography - 6. Left ventricular diastolic function - 3 (DT, IVRT). DT (Half-time of wave E) | 254.7 ms. STANDARD_DEVIATION 51.4 | 252.3 ms. STANDARD_DEVIATION 55.1 | 257.6 ms. STANDARD_DEVIATION 46.3 | 253 ms. STANDARD_DEVIATION 52.7 |
| Echocardiography - 6. Left ventricular diastolic function - 3 (DT, IVRT). IVRT (time of isovolumic relaxation of the left ventriclar) | 104.7 ms. STANDARD_DEVIATION 11.6 | 105.3 ms. STANDARD_DEVIATION 13.9 | 106 ms. STANDARD_DEVIATION 9.8 | 103.4 ms. STANDARD_DEVIATION 11.1 |
| Echocardiography - 7. LVmass/ BSA (g/m^2) | 135.3 g/m^2 STANDARD_DEVIATION 36.3 | 134.04 g/m^2 STANDARD_DEVIATION 32 | 152.8 g/m^2 STANDARD_DEVIATION 48 | 119.1 g/m^2 STANDARD_DEVIATION 29 |
| Echocardiography - 8. RWT - relative wall thickness of the left ventricle. | 0.43 ratio STANDARD_DEVIATION 0.07 | 0.4 ratio STANDARD_DEVIATION 0.06 | 0.4 ratio STANDARD_DEVIATION 0.07 | 0.44 ratio STANDARD_DEVIATION 0.07 |
| Echocardiography - 9. Mitral regurgitation. 1 degree Mitral regurgitation. | 45 Participants | 13 Participants | 13 Participants | 19 Participants |
| Echocardiography - 9. Mitral regurgitation. 2 degree Mitral regurgitation. | 8 Participants | 3 Participants | 3 Participants | 2 Participants |
| Echocardiography - 9. Mitral regurgitation. 3 degree Mitral regurgitation. | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Echocardiography - 9. Mitral regurgitation. Not | 30 Participants | 6 Participants | 8 Participants | 16 Participants |
| EuroScore II | 1.15 percentage of risk STANDARD_DEVIATION 0.5 | 1.02 percentage of risk STANDARD_DEVIATION 0.4 | 1.07 percentage of risk STANDARD_DEVIATION 0.47 | 1.3 percentage of risk STANDARD_DEVIATION 0.68 |
| Family history of cardiovascular disease. | 40 Participants | 10 Participants | 11 Participants | 19 Participants |
| Glomerular filtration rate (ml/min/1.73 m^2) (assessment of renal function). | 77.9 ml/min/1.73 m^2 STANDARD_DEVIATION 16.8 | 84.2 ml/min/1.73 m^2 STANDARD_DEVIATION 17.26 | 77.6 ml/min/1.73 m^2 STANDARD_DEVIATION 16.03 | 79.89 ml/min/1.73 m^2 STANDARD_DEVIATION 15.8 |
| Heart failure (functional class NYHA). 1 functional class | 8 Participants | 2 Participants | 1 Participants | 5 Participants |
| Heart failure (functional class NYHA). 2 functional class | 74 Participants | 21 Participants | 24 Participants | 29 Participants |
| Heart failure (functional class NYHA). 3 functional class | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| High density lipoproteins (mmol/l). | 2.6 mmol/l STANDARD_DEVIATION 1.1 | 2.7 mmol/l STANDARD_DEVIATION 1.26 | 2.58 mmol/l STANDARD_DEVIATION 1.05 | 2.7 mmol/l STANDARD_DEVIATION 0.89 |
| Hypertonic desease (stage). 2 stage | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Hypertonic desease (stage). 3 stage | 84 Participants | 23 Participants | 25 Participants | 36 Participants |
| Loud density lipoproteins (mmol/l). | 1.1 mmol/l STANDARD_DEVIATION 0.3 | 1.13 mmol/l STANDARD_DEVIATION 0.29 | 1.16 mmol/l STANDARD_DEVIATION 0.37 | 0.98 mmol/l STANDARD_DEVIATION 0.31 |
| Nitrates. | 42 Participants | 10 Participants | 11 Participants | 21 Participants |
| Peripheral arteriopathy. | 21 Participants | 6 Participants | 4 Participants | 11 Participants |
| Region of Enrollment Russia | 85 participants | 23 participants | 25 participants | 37 participants |
| Sex: Female, Male Female | 13 Participants | 3 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 72 Participants | 20 Participants | 21 Participants | 31 Participants |
| Smoking. | 13 Participants | 4 Participants | 2 Participants | 7 Participants |
| Statins. | 58 Participants | 15 Participants | 16 Participants | 27 Participants |
| SYNTAX Score | 26.7 units on a scale STANDARD_DEVIATION 6.4 | 26.4 units on a scale STANDARD_DEVIATION 7.3 | 26.8 units on a scale STANDARD_DEVIATION 6 | 26.7 units on a scale STANDARD_DEVIATION 7 |
| Total holesterol (mmol/l). | 4.5 mmol/l STANDARD_DEVIATION 1.1 | 4.6 mmol/l STANDARD_DEVIATION 1.49 | 4.5 mmol/l STANDARD_DEVIATION 1.24 | 4.49 mmol/l STANDARD_DEVIATION 1.08 |
| Triglyceride (mmol/l). | 1.9 mmol/l STANDARD_DEVIATION 0.65 | 1.63 mmol/l STANDARD_DEVIATION 0.62 | 1.69 mmol/l STANDARD_DEVIATION 0.72 | 2.04 mmol/l STANDARD_DEVIATION 0.68 |
| Very loud density lipoprotein (mmol/l). | 0.95 mmol/l STANDARD_DEVIATION 0.31 | 0.77 mmol/l STANDARD_DEVIATION 0.3 | 0.94 mmol/l STANDARD_DEVIATION 0.5 | 0.96 mmol/l STANDARD_DEVIATION 0.35 |
| β-blockers. | 78 Participants | 23 Participants | 20 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 25 | 0 / 23 |
| other Total, other adverse events | 0 / 37 | 0 / 25 | 0 / 23 |
| serious Total, serious adverse events | 0 / 37 | 0 / 25 | 0 / 23 |
Outcome results
Primary
Assessment of Complications in the Postoperative Period. Additional Estimation of Safety.
The presence of complications in the postoperative period (Hydrothorax, Hydropericardium, Cardiac arrhythmias - atrial fibrillation / atrial flutter).
Time frame: Postoperative period.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 0 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Hydrothorax / postoperative period | 3 participants |
| Group 0 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Hydropericardium / postoperative period | 0 participants |
| Group 0 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Resternotomy / postoperative period | 1 participants |
| Group 0 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Atrial fibrillation / postoperative period | 8 participants |
| Group 0 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Atrial flutter / postoperative period | 4 participants |
| Group 1 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Atrial fibrillation / postoperative period | 4 participants |
| Group 1 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Hydrothorax / postoperative period | 4 participants |
| Group 1 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Hydropericardium / postoperative period | 1 participants |
| Group 1 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Atrial flutter / postoperative period | 0 participants |
| Group 1 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Resternotomy / postoperative period | 1 participants |
| Group 2 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Atrial flutter / postoperative period | 0 participants |
| Group 2 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Resternotomy / postoperative period | 0 participants |
| Group 2 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Atrial fibrillation / postoperative period | 9 participants |
| Group 2 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Hydropericardium / postoperative period | 2 participants |
| Group 2 | Assessment of Complications in the Postoperative Period. Additional Estimation of Safety. | Hydrothorax / postoperative period | 3 participants |
Comparison: Hydrothorax / postoperative period.p-value: 0.6Chi-squared
Comparison: Hydropericardium / postoperative period.p-value: 0.2Chi-squared
Comparison: Resternotomy / postoperative period.p-value: 0.6Chi-squared
Comparison: Atrial fibrillation / postoperative period.p-value: 0.06Chi-squared
Comparison: Atrial flutter / postoperative period.p-value: 0.06Chi-squared
Primary
Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety.
Assessment of myocardial contractility according to echocardiography, in particular the size of the left ventricle - its index, was carried out within 7-14 days of the postoperative period, depending on the clinical condition of the patient, as well as on the maximum information content of this study. The higher the indicator (left ventricular size - index), the worse the prognosis of an unfavorable outcome. The index is used as an indicator of payment to obtain a more reliable result (taking into account the individual characteristics of each patient). index - left ventricular size (mm.)/ body mass index (kg/m\^2).
Time frame: 7-14 days after surgery
Population: All patients included in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. | Lvs ind. | 1.8 mm/m^2 | Standard Deviation 0.07 |
| Group 0 | Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. | Lvd ind. | 2.6 mm/m^2 | Standard Deviation 0.08 |
| Group 0 | Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. | LAind. | 2 mm/m^2 | Standard Deviation 0.06 |
| Group 1 | Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. | Lvs ind. | 2.1 mm/m^2 | Standard Deviation 0.09 |
| Group 1 | Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. | Lvd ind. | 3 mm/m^2 | Standard Deviation 0.1 |
| Group 1 | Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. | LAind. | 2.2 mm/m^2 | Standard Deviation 0.07 |
| Group 2 | Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. | Lvs ind. | 1.9 mm/m^2 | Standard Deviation 0.09 |
| Group 2 | Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. | LAind. | 2.1 mm/m^2 | Standard Deviation 0.08 |
| Group 2 | Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety. | Lvd ind. | 2.7 mm/m^2 | Standard Deviation 0.1 |
Comparison: Lvd ind. (Lvd mm./BSA kg / cm) - Evaluation of the left ventricular end-diastolic size index.p-value: 0.5RepeatedMeasures ANOVA
Comparison: Lvs ind. (Lvs mm./BSA kg / cm) - Evaluation of the left ventricular end-systolic size index.p-value: 0.5RepeatedMeasures ANOVA
Comparison: LAind. (LA mm./BSA kg / cm) - Left Atrial Size Index Assessment.p-value: 0.6RepeatedMeasures ANOVA
Primary
Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)),
Results of dynamic control of laboratory parameters of CRP. C-reactive protein. This fraction of plasma proteins increases in the presence of an inflammatory process in the body. It is synthesized in response to the ingestion of toxins of pathological microorganisms into the bloodstream and neutralizes them by binding them. In addition, it appears when the body's own cells are destroyed in the event of necrosis, tumor disintegration or extensive trauma, inactivating the resulting products. In addition to eliminating toxins, CRP triggers a cascade of immune responses aimed at eliminating pathologically altered structures. Normally absent (or less than 0.4 mg / l). In the statistical analysis, the grouping of indicators in the indicated intervals was used, in view of the individual characteristics of the course of the postoperative period in each case.
Time frame: Initial data, control point in the interval 4-6 days of the postoperative period, control point in the interval 12-14 days of the postoperative period.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), | CRP control point in the interval 12-14 days of the postoperative period/ mg/l | 24.6 mg/l | Standard Deviation 13.8 |
| Group 0 | Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), | CRP initially/ mg / l | 4.4 mg/l | Standard Deviation 6.05 |
| Group 0 | Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), | CRP control point in the interval 4-6 days of the postoperative period/ mg/l | 80.2 mg/l | Standard Deviation 38 |
| Group 1 | Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), | CRP control point in the interval 4-6 days of the postoperative period/ mg/l | 85.9 mg/l | Standard Deviation 51.8 |
| Group 1 | Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), | CRP control point in the interval 12-14 days of the postoperative period/ mg/l | 25.9 mg/l | Standard Deviation 20.9 |
| Group 1 | Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), | CRP initially/ mg / l | 3.05 mg/l | Standard Deviation 2 |
| Group 2 | Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), | CRP initially/ mg / l | 5.1 mg/l | Standard Deviation 5.1 |
| Group 2 | Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), | CRP control point in the interval 12-14 days of the postoperative period/ mg/l | 24.4 mg/l | Standard Deviation 15.6 |
| Group 2 | Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)), | CRP control point in the interval 4-6 days of the postoperative period/ mg/l | 121.1 mg/l | Standard Deviation 76.3 |
Comparison: CRP initially.p-value: 0.1Kruskal-Wallis
Comparison: CRP postoperative 4-6 days.p-value: 0.4Kruskal-Wallis
Comparison: CRP postoperative 12-14 days.p-value: 0.99Kruskal-Wallis
Primary
Assessment of the Initial Risk of Surgery (EuroScore II).
EuroScoreII is intended to assess the risk of adverse outcome of coronary artery bypass grafting. Assessment factors: age, sex, serum creatinine, extracardiac artery disease, chronic lung disease, severe neurological disorders, previous cardiac surgery, previous myocardial infarction, left ventricular dysfunction, diabetes mellitus, pulmonary hypertension, IV class of angina severity, active endocarditis, unstable angina, surgery, critical condition of the patient before surgery, type of surgery. The higher the percentage, the higher the risk of surgery.
Time frame: Before CABG surgery at baseline.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 0 | Assessment of the Initial Risk of Surgery (EuroScore II). | 1.3 percent | Standard Deviation 0.68 |
| Group 1 | Assessment of the Initial Risk of Surgery (EuroScore II). | 1.07 percent | Standard Deviation 0.47 |
| Group 2 | Assessment of the Initial Risk of Surgery (EuroScore II). | 1.02 percent | Standard Deviation 0.4 |
p-value: 0.24Kruskal-Wallis
Primary
Cardiopulmonary Bypass Time.
Time frame: Intraoperative data.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 0 | Cardiopulmonary Bypass Time. | 135 minutes | Standard Deviation 31.6 |
| Group 1 | Cardiopulmonary Bypass Time. | 122.8 minutes | Standard Deviation 19.7 |
| Group 2 | Cardiopulmonary Bypass Time. | 144 minutes | Standard Deviation 29.2 |
p-value: 0.1Kruskal-Wallis
Primary
Dynamics of Markers of Myocardial Damage (Creatine Phosphokinase Fraction MB (CPK-MB)).
Assessment of the severity of the period of ischemia / reperfusion. And the effect of autologous bone marrow mononuclear cells transplantation on these indicators.
Time frame: 1 and 3 days of the postoperative period.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Dynamics of Markers of Myocardial Damage (Creatine Phosphokinase Fraction MB (CPK-MB)). | CPK-MB postoperative day 1/ U/l | 62.3 U/l | Standard Deviation 1024 |
| Group 0 | Dynamics of Markers of Myocardial Damage (Creatine Phosphokinase Fraction MB (CPK-MB)). | CPK-MB postoperative day 3/ U/l | 35.4 U/l | Standard Deviation 84.7 |
| Group 1 | Dynamics of Markers of Myocardial Damage (Creatine Phosphokinase Fraction MB (CPK-MB)). | CPK-MB postoperative day 1/ U/l | 63.02 U/l | Standard Deviation 79.2 |
| Group 1 | Dynamics of Markers of Myocardial Damage (Creatine Phosphokinase Fraction MB (CPK-MB)). | CPK-MB postoperative day 3/ U/l | 9.5 U/l | Standard Deviation 9.3 |
| Group 2 | Dynamics of Markers of Myocardial Damage (Creatine Phosphokinase Fraction MB (CPK-MB)). | CPK-MB postoperative day 1/ U/l | 78.6 U/l | Standard Deviation 136.8 |
| Group 2 | Dynamics of Markers of Myocardial Damage (Creatine Phosphokinase Fraction MB (CPK-MB)). | CPK-MB postoperative day 3/ U/l | 4.6 U/l | Standard Deviation 1.9 |
Comparison: CPK-MB postoperative day 1.p-value: 0.7Kruskal-Wallis
Comparison: CPK-MB postoperative day 3.p-value: 0.8Kruskal-Wallis
Primary
Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin).
Assessment of the severity of the period of ischemia / reperfusion. And the effect of autologous bone marrow mononuclear cells transplantation on these indicators.
Time frame: 1 and 3 days of the postoperative period.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | Troponin I (postoperative day 3)/mcg / l | 19.6 mcg / l | Standard Deviation 31.9 |
| Group 0 | Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | Myoglobin postoperative day 3/mcg / l | 92.5 mcg / l | Standard Deviation 1094.8 |
| Group 0 | Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | Myoglobin postoperative day 1/mcg / l/ | 522.8 mcg / l | Standard Deviation 711.6 |
| Group 0 | Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | Troponin I (postoperative day 1)/mcg / l | 12.05 mcg / l | Standard Deviation 18.9 |
| Group 1 | Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | Troponin I (postoperative day 3)/mcg / l | 3.08 mcg / l | Standard Deviation 3.7 |
| Group 1 | Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | Troponin I (postoperative day 1)/mcg / l | 5.7 mcg / l | Standard Deviation 5.8 |
| Group 1 | Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | Myoglobin postoperative day 3/mcg / l | 71.4 mcg / l | Standard Deviation 41.4 |
| Group 1 | Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | Myoglobin postoperative day 1/mcg / l/ | 385.6 mcg / l | Standard Deviation 221.7 |
| Group 2 | Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | Myoglobin postoperative day 3/mcg / l | 70.4 mcg / l | Standard Deviation 148.4 |
| Group 2 | Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | Myoglobin postoperative day 1/mcg / l/ | 757.2 mcg / l | Standard Deviation 1146.8 |
| Group 2 | Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | Troponin I (postoperative day 1)/mcg / l | 2.9 mcg / l | Standard Deviation 2.3 |
| Group 2 | Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin). | Troponin I (postoperative day 3)/mcg / l | 1.9 mcg / l | Standard Deviation 1.3 |
Comparison: Troponin I postoperative day 1.p-value: 0.6Kruskal-Wallis
Comparison: Troponin I postoperative day 3.p-value: 0.4Kruskal-Wallis
Comparison: Myoglobin postoperative day 1.p-value: 0.8Kruskal-Wallis
Comparison: Myoglobin postoperative day 3.p-value: 0.7Kruskal-Wallis
Primary
Intraoperative Assessment of Homeostasis (Hematocrit (HCT)).
These parameters were evaluated at the end of the cardiopulmonary bypass and at the end of the surgery. The interval between indicators is on average from 60 to 120 minutes.
Time frame: Intraoperative data.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Intraoperative Assessment of Homeostasis (Hematocrit (HCT)). | HCT intraoperatively before turning off the cardiopulmonary bypass(CPB). | 23.4 percent | Standard Deviation 4.2 |
| Group 0 | Intraoperative Assessment of Homeostasis (Hematocrit (HCT)). | HCT at the end of the operation. | 29.3 percent | Standard Deviation 5.2 |
| Group 1 | Intraoperative Assessment of Homeostasis (Hematocrit (HCT)). | HCT intraoperatively before turning off the cardiopulmonary bypass(CPB). | 22.2 percent | Standard Deviation 1.9 |
| Group 1 | Intraoperative Assessment of Homeostasis (Hematocrit (HCT)). | HCT at the end of the operation. | 27.8 percent | Standard Deviation 3.2 |
| Group 2 | Intraoperative Assessment of Homeostasis (Hematocrit (HCT)). | HCT intraoperatively before turning off the cardiopulmonary bypass(CPB). | 23.2 percent | Standard Deviation 3.9 |
| Group 2 | Intraoperative Assessment of Homeostasis (Hematocrit (HCT)). | HCT at the end of the operation. | 25.7 percent | Standard Deviation 3.1 |
Comparison: HCT intraoperatively before turning off the cardiopulmonary bypass (CPB).p-value: 0.8Kruskal-Wallis
Comparison: HCT at the end of the operation.p-value: 0.3Kruskal-Wallis
Primary
Intraoperative Assessment of Homeostasis (Hemoglobin (Hb).
These parameters were evaluated at the end of the cardiopulmonary bypass and at the end of the surgery. The interval between indicators is on average from 60 to 120 minutes.
Time frame: Intraoperative data.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Intraoperative Assessment of Homeostasis (Hemoglobin (Hb). | Hb at the end of the operation. | 91.3 g/l | Standard Deviation 16.09 |
| Group 0 | Intraoperative Assessment of Homeostasis (Hemoglobin (Hb). | Hb intraoperatively before turning off the cardiopulmonary bypass (CPB). | 74.05 g/l | Standard Deviation 12.2 |
| Group 1 | Intraoperative Assessment of Homeostasis (Hemoglobin (Hb). | Hb at the end of the operation. | 91.5 g/l | Standard Deviation 8.6 |
| Group 1 | Intraoperative Assessment of Homeostasis (Hemoglobin (Hb). | Hb intraoperatively before turning off the cardiopulmonary bypass (CPB). | 73.4 g/l | Standard Deviation 8.08 |
| Group 2 | Intraoperative Assessment of Homeostasis (Hemoglobin (Hb). | Hb at the end of the operation. | 86.7 g/l | Standard Deviation 11.1 |
| Group 2 | Intraoperative Assessment of Homeostasis (Hemoglobin (Hb). | Hb intraoperatively before turning off the cardiopulmonary bypass (CPB). | 75.8 g/l | Standard Deviation 14.5 |
Comparison: Hb intraoperatively before turning off the cardiopulmonary bypass(CPB).p-value: 1Kruskal-Wallis
Comparison: Hb at the end of the operation.p-value: 0.4Kruskal-Wallis
Primary
Intraoperative Assessment of Homeostasis (К+).
These parameters were evaluated at the end of the cardiopulmonary bypass and at the end of the surgery. The interval between indicators is on average from 60 to 120 minutes.
Time frame: Intraoperative data.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Intraoperative Assessment of Homeostasis (К+). | K+ intraoperatively before turning off the cardiopulmonary bypass(CPB). | 5.01 mmol/l | Standard Deviation 0.59 |
| Group 0 | Intraoperative Assessment of Homeostasis (К+). | K+ at the end of the operation. | 3.9 mmol/l | Standard Deviation 0.4 |
| Group 1 | Intraoperative Assessment of Homeostasis (К+). | K+ intraoperatively before turning off the cardiopulmonary bypass(CPB). | 5.4 mmol/l | Standard Deviation 0.9 |
| Group 1 | Intraoperative Assessment of Homeostasis (К+). | K+ at the end of the operation. | 4.5 mmol/l | Standard Deviation 0.6 |
| Group 2 | Intraoperative Assessment of Homeostasis (К+). | K+ intraoperatively before turning off the cardiopulmonary bypass(CPB). | 4.7 mmol/l | Standard Deviation 0.9 |
| Group 2 | Intraoperative Assessment of Homeostasis (К+). | K+ at the end of the operation. | 3.9 mmol/l | Standard Deviation 0.5 |
Comparison: K+ intraoperatively before turning off the cardiopulmonary bypass (CPB).p-value: 0.4Kruskal-Wallis
Comparison: K+ at the end of the operation.p-value: 0.1Kruskal-Wallis
Primary
Left Ventricular Ejection Fraction - Echocardiography - Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety.
Evaluation of myocardial contractility according to echocardiography, in particular the left ventricular ejection fraction, was carried out within 7-14 days of the postoperative period, depending on the patient's clinical condition, as well as the maximum degree of information content of this study. The lower the indicator, the worse the prognosis of an unfavorable outcome.
Time frame: 7-14 days of the postoperative period
Population: all patients included in the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 0 | Left Ventricular Ejection Fraction - Echocardiography - Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. | 62.1 percent | Standard Deviation 1.6 |
| Group 1 | Left Ventricular Ejection Fraction - Echocardiography - Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. | 56.4 percent | Standard Deviation 2 |
| Group 2 | Left Ventricular Ejection Fraction - Echocardiography - Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. | 55.9 percent | Standard Deviation 2.1 |
p-value: 0.4RepeatedMeasures ANOVA
Primary
Length of Hospital Stay. Length of Stay in the Intensive Care Unit.
The results were obtained from the analysis of primary data.
Time frame: Primary hospitalization for planned CABG.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Length of Hospital Stay. Length of Stay in the Intensive Care Unit. | Hospital Stay | 36.8 days | Standard Deviation 11.2 |
| Group 0 | Length of Hospital Stay. Length of Stay in the Intensive Care Unit. | Days in the intensive care unite | 3.9 days | Standard Deviation 2.2 |
| Group 1 | Length of Hospital Stay. Length of Stay in the Intensive Care Unit. | Hospital Stay | 32.8 days | Standard Deviation 13.9 |
| Group 1 | Length of Hospital Stay. Length of Stay in the Intensive Care Unit. | Days in the intensive care unite | 3.1 days | Standard Deviation 1.7 |
| Group 2 | Length of Hospital Stay. Length of Stay in the Intensive Care Unit. | Hospital Stay | 38.4 days | Standard Deviation 15.2 |
| Group 2 | Length of Hospital Stay. Length of Stay in the Intensive Care Unit. | Days in the intensive care unite | 3.3 days | Standard Deviation 1.8 |
Comparison: Length of hospital stay.p-value: 0.1Kruskal-Wallis
Comparison: Length of stay in the intensive care unit.p-value: 0.1Kruskal-Wallis
Primary
Restoration of the Heart Rate After the Completion of the Main Stage of the Surgical Intervention. Additional Estimation of Safety.
The need to perform defibrillation to restore sinus rhythm, at the end of the main stage of surgery.
Time frame: Upon completion of the main stage of surgery.
Population: All patients included in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 0 | Restoration of the Heart Rate After the Completion of the Main Stage of the Surgical Intervention. Additional Estimation of Safety. | 3 Participants |
| Group 1 | Restoration of the Heart Rate After the Completion of the Main Stage of the Surgical Intervention. Additional Estimation of Safety. | 3 Participants |
| Group 2 | Restoration of the Heart Rate After the Completion of the Main Stage of the Surgical Intervention. Additional Estimation of Safety. | 4 Participants |
p-value: 0.6Chi-squared
Primary
The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis).
Assessment of the severity of the systemic inflammatory response during hospital stay after surgery. Assessment of the level of inflammation by the severity of an increase in leukocytes (leukocytosis). Leukocytosis - an increase in the number of leukocytes per unit volume of blood. The norm of leukocytes in the blood is 5.5-8.810\^9 /l. For adults, leukocytosis is considered to be an increase in the number of leukocytes in the blood of more than 9.0\*10\^9 / l In the statistical analysis, the grouping of indicators in the indicated intervals was used, in view of the individual characteristics of the course of the postoperative period in each case.
Time frame: The parameters were evaluated initially at baseline in the postoperative period - an interval of 0-6 hours, 12-18 hours, 18-24 hours, 48 hours, 72 hours, 96 hours, 7 days and 14 days.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 14 days | 8.8 x10^9 cells/L | Standard Deviation 1.6 |
| Group 0 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period - an interval of 0-6 hours | 13.9 x10^9 cells/L | Standard Deviation 6.3 |
| Group 0 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period - an interval of 12-18 hours | 13.9 x10^9 cells/L | Standard Deviation 3.99 |
| Group 0 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period - an interval of 18-24 hours | 13.08 x10^9 cells/L | Standard Deviation 2.4 |
| Group 0 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 72 hours | 11.3 x10^9 cells/L | Standard Deviation 4.1 |
| Group 0 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 96 hours | 10.1 x10^9 cells/L | Standard Deviation 2.7 |
| Group 0 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu (leukocytes) / initially | 8.3 x10^9 cells/L | Standard Deviation 2.2 |
| Group 0 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 48 hours | 13.8 x10^9 cells/L | Standard Deviation 5.5 |
| Group 0 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 7 days | 11.9 x10^9 cells/L | Standard Deviation 5.9 |
| Group 1 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 14 days | 8.8 x10^9 cells/L | Standard Deviation 1.7 |
| Group 1 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu (leukocytes) / initially | 6.5 x10^9 cells/L | Standard Deviation 1.5 |
| Group 1 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 48 hours | 14.8 x10^9 cells/L | Standard Deviation 2.2 |
| Group 1 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 7 days | 9.5 x10^9 cells/L | Standard Deviation 2.3 |
| Group 1 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 72 hours | 9.4 x10^9 cells/L | Standard Deviation 1.6 |
| Group 1 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period - an interval of 12-18 hours | 14.7 x10^9 cells/L | Standard Deviation 5.9 |
| Group 1 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period - an interval of 0-6 hours | 14.1 x10^9 cells/L | Standard Deviation 1.9 |
| Group 1 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 96 hours | 8.7 x10^9 cells/L | Standard Deviation 2.6 |
| Group 1 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period - an interval of 18-24 hours | 15.4 x10^9 cells/L | Standard Deviation 2.4 |
| Group 2 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 7 days | 10.4 x10^9 cells/L | Standard Deviation 3.2 |
| Group 2 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 48 hours | 13.3 x10^9 cells/L | Standard Deviation 3.97 |
| Group 2 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 96 hours | 10.4 x10^9 cells/L | Standard Deviation 1.99 |
| Group 2 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 72 hours | 11.4 x10^9 cells/L | Standard Deviation 1.9 |
| Group 2 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period 14 days | 10.4 x10^9 cells/L | Standard Deviation 3.06 |
| Group 2 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period - an interval of 18-24 hours | 16.99 x10^9 cells/L | Standard Deviation 3.9 |
| Group 2 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu (leukocytes) / initially | 7.3 x10^9 cells/L | Standard Deviation 2.04 |
| Group 2 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period - an interval of 0-6 hours | 16.2 x10^9 cells/L | Standard Deviation 5.4 |
| Group 2 | The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis). | Leu / in the postoperative period - an interval of 12-18 hours | 13.3 x10^9 cells/L | Standard Deviation 3.7 |
p-value: 0.4Kruskal-Wallis
Comparison: Analysis of leukocytes 0-6 hours of the postoperative period.p-value: 0.8Kruskal-Wallis
Comparison: Analysis of leukocytes 12-18 hours of the postoperative period.p-value: 0.9Kruskal-Wallis
Comparison: Analysis of leukocytes 18-24 hours of the postoperative period.p-value: 0.2Kruskal-Wallis
Comparison: Analysis of leukocytes 48 hours of the postoperative period.p-value: 0.5Kruskal-Wallis
Comparison: Analysis of leukocytes 72 hours of the postoperative period.p-value: 0.4Kruskal-Wallis
Comparison: Analysis of leukocytes 96 hours of the postoperative period/p-value: 0.6Kruskal-Wallis
Comparison: Analysis of leukocytes 7 days of the postoperative period.p-value: 0.4Kruskal-Wallis
Comparison: Analysis of leukocytes 14 days of the postoperative period.p-value: 0.5Kruskal-Wallis
Primary
The Volume of Discharge Through the Drains in the Early Postoperative Period.
A daily assessment of the discharge by drainage before removal was carried out. It was carried out to assess the possible development of an excessive inflammatory reaction (polyserositis phenomena) in response to the transplantation of autologous bone marrow mononuclear cells.
Time frame: Evaluation of these data - for the time spent in the intensive care unit before removing the drains.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | The Volume of Discharge Through the Drains in the Early Postoperative Period. | The volume of discharge through the drains on the first day after surgery. | 541.2 milliliters | Standard Error 47.9 |
| Group 0 | The Volume of Discharge Through the Drains in the Early Postoperative Period. | The volume of discharge through the drains on the second day after the operation. | 189.7 milliliters | Standard Error 27.1 |
| Group 1 | The Volume of Discharge Through the Drains in the Early Postoperative Period. | The volume of discharge through the drains on the first day after surgery. | 424 milliliters | Standard Error 95.7 |
| Group 1 | The Volume of Discharge Through the Drains in the Early Postoperative Period. | The volume of discharge through the drains on the second day after the operation. | 152 milliliters | Standard Error 54.2 |
| Group 2 | The Volume of Discharge Through the Drains in the Early Postoperative Period. | The volume of discharge through the drains on the first day after surgery. | 410 milliliters | Standard Error 59.4 |
| Group 2 | The Volume of Discharge Through the Drains in the Early Postoperative Period. | The volume of discharge through the drains on the second day after the operation. | 195.4 milliliters | Standard Error 33.6 |
Comparison: The volume of discharge through the drains on the first day after surgery.p-value: 0.2Kruskal-Wallis
Comparison: The volume of discharge through the drains on the second day after the operation.p-value: 0.3RepeatedMeasures ANOVA
Primary
Time of Aortic Clamping (Anoxia).
Estimation of the time from the moment the clamp is applied to the aorta (complete clamping of the aorta) to the removal of the clamp from the aorta.
Time frame: Intraoperative data.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 0 | Time of Aortic Clamping (Anoxia). | 75.8 minutes | Standard Deviation 17.6 |
| Group 1 | Time of Aortic Clamping (Anoxia). | 73.8 minutes | Standard Deviation 22.3 |
| Group 2 | Time of Aortic Clamping (Anoxia). | 84 minutes | Standard Deviation 18.8 |
p-value: 0.1Kruskal-Wallis
Primary
Volume of the Left Ventricle - Index - Echocardiography. Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety.
Evaluation of myocardial contractility according to echocardiography, in particular volume of the left ventricle - index was carried out within 7-14 days of the postoperative period, depending on the patient's clinical condition, as well as the maximum degree of information content of this study. The greater the figure (volume of the left ventricle - index), the worse the prognosis of adverse outcome. The index is used as an indicator of the payment to obtain a more reliable result (taking into account individual characteristics of each patient). index - volume of the left ventricle (ml.)/ body mass index (kg / m\^2).
Time frame: 7-14 days after surgery
Population: All patients included in the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Volume of the Left Ventricle - Index - Echocardiography. Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. | LVESV MOD BP ind. | 23.5 mL/m^2 | Standard Deviation 3 |
| Group 0 | Volume of the Left Ventricle - Index - Echocardiography. Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. | LVEDV MOD BP ind | 58.8 mL/m^2 | Standard Deviation 4.8 |
| Group 1 | Volume of the Left Ventricle - Index - Echocardiography. Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. | LVEDV MOD BP ind | 70.9 mL/m^2 | Standard Deviation 6.9 |
| Group 1 | Volume of the Left Ventricle - Index - Echocardiography. Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. | LVESV MOD BP ind. | 31.9 mL/m^2 | Standard Deviation 4.4 |
| Group 2 | Volume of the Left Ventricle - Index - Echocardiography. Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. | LVEDV MOD BP ind | 63.9 mL/m^2 | Standard Deviation 5.9 |
| Group 2 | Volume of the Left Ventricle - Index - Echocardiography. Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety. | LVESV MOD BP ind. | 27.8 mL/m^2 | Standard Deviation 3.7 |
Comparison: LVEDV MOD BP ind. (LVEDV MOD BP ml./BSA kg / cm) - Evaluation of the left ventricular end-diastolic volume index.p-value: 0.4RepeatedMeasures ANOVA
Comparison: Evaluation of the left ventricular end-systolic volume index (LVESV MOD BP ind.)p-value: 0.3RepeatedMeasures ANOVA
Secondary
All-cause Mortality Associated With the Progression of Basic Disease.
The total number of deaths - in the primary hospitalization and during the observation period of 12 months after surgical treatment - deaths associated with the progression of the initial disease. The complication rate for CABG operations is 30±10%. According to n1=kn2; n1 sample size, in the control. In group 0, k=2/3 times more than in group 1 and group 2. The difference between the test and control frequencies is ε=p1-p2. Accordingly, with p1 = 0.2; p2=0.4, δ= 0.1; n1=49.5, n2=33. The result is group 0 - 36, group 1 and 2 - 25+25 = 50. The null hypothesis of complication rate δ.All patients included in the study.
Time frame: 12 months after surgery
Population: All patients included in the study (groups 1 and 2) were compared with the control group (Group 0).In patients included in study during the observation period after the treatment there was no progression of the underlying disease that was fatal.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 0 | All-cause Mortality Associated With the Progression of Basic Disease. | 0 participants |
| Group 1 | All-cause Mortality Associated With the Progression of Basic Disease. | 0 participants |
| Group 2 | All-cause Mortality Associated With the Progression of Basic Disease. | 0 participants |
Secondary
Analysis of the Effect of Left Ventricular Diastolic Dysfunction on the Patency of the Grafts.
Echocardiographic data.
Time frame: up to 12 months
Population: All patients included in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 0 | Analysis of the Effect of Left Ventricular Diastolic Dysfunction on the Patency of the Grafts. | Number of patients with non-functioning grafts | 10 Participants |
| Group 0 | Analysis of the Effect of Left Ventricular Diastolic Dysfunction on the Patency of the Grafts. | Patients with non-functioning grafts in the presence of LV diastolic dysfunction after 12 months. | 8 Participants |
| Group 1 | Analysis of the Effect of Left Ventricular Diastolic Dysfunction on the Patency of the Grafts. | Number of patients with non-functioning grafts | 1 Participants |
| Group 1 | Analysis of the Effect of Left Ventricular Diastolic Dysfunction on the Patency of the Grafts. | Patients with non-functioning grafts in the presence of LV diastolic dysfunction after 12 months. | 0 Participants |
| Group 2 | Analysis of the Effect of Left Ventricular Diastolic Dysfunction on the Patency of the Grafts. | Number of patients with non-functioning grafts | 2 Participants |
| Group 2 | Analysis of the Effect of Left Ventricular Diastolic Dysfunction on the Patency of the Grafts. | Patients with non-functioning grafts in the presence of LV diastolic dysfunction after 12 months. | 1 Participants |
p-value: 0.05Chi-squared
Secondary
Assessment of Left Ventricular Diastolic Function - DT and IVRT 12 Months After Treatment.
Echocardiographic data ( DT (Half-time of wave E), time of isovolumic relaxation of the left ventricle (IVRT). DT (Half-time of wave E). The DT time index reflects the relaxation process LV, LV diastolic pressure after mitral valve opening, and LV compliance. 150-200 ms - normal; \> 200 ms - violation of relaxation; 150-200 ms - pseudonormal type of left ventricular filling; \<150 ms - restrictive type of diastolic dysfunction IVRT (time of isovolumic relaxation of the left ventricl.) \<100 ms - normal; \> 100 ms - violation of relaxation
Time frame: 12 Months After Treatment.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Assessment of Left Ventricular Diastolic Function - DT and IVRT 12 Months After Treatment. | DT (Half-time of wave E). | 250.4 ms | Standard Deviation 15.2 |
| Group 0 | Assessment of Left Ventricular Diastolic Function - DT and IVRT 12 Months After Treatment. | time of isovolumic relaxation of the left ventricle (IVRT). | 96.9 ms | Standard Deviation 4.1 |
| Group 1 | Assessment of Left Ventricular Diastolic Function - DT and IVRT 12 Months After Treatment. | DT (Half-time of wave E). | 252.6 ms | Standard Deviation 20.08 |
| Group 1 | Assessment of Left Ventricular Diastolic Function - DT and IVRT 12 Months After Treatment. | time of isovolumic relaxation of the left ventricle (IVRT). | 102.4 ms | Standard Deviation 5.5 |
| Group 2 | Assessment of Left Ventricular Diastolic Function - DT and IVRT 12 Months After Treatment. | DT (Half-time of wave E). | 256.6 ms | Standard Deviation 18.3 |
| Group 2 | Assessment of Left Ventricular Diastolic Function - DT and IVRT 12 Months After Treatment. | time of isovolumic relaxation of the left ventricle (IVRT). | 99.6 ms | Standard Deviation 4.9 |
Comparison: DT (Half-time of wave E).p-value: 0.9RepeatedMeasures ANOVA
Comparison: time of isovolumic relaxation of the left ventriclep-value: 0.9RepeatedMeasures ANOVA
Secondary
Assessment of Left Ventricular Diastolic Function E/A - 12 Months After Treatment.
The ratio of the transmitral flow, wave E (ejection wave / left ventricular contraction) to wave A (ejection wave / left atrial contraction). The norm is 0.75-1.5 Less than 0.75 violation of relaxation, more than 1.5 restrictive type of diastolic dysfunction.
Time frame: 12 months after treatment
Population: All patients included in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 0 | Assessment of Left Ventricular Diastolic Function E/A - 12 Months After Treatment. | 1 ratio | Standard Deviation 0.1 |
| Group 1 | Assessment of Left Ventricular Diastolic Function E/A - 12 Months After Treatment. | 1.2 ratio | Standard Deviation 0.1 |
| Group 2 | Assessment of Left Ventricular Diastolic Function E/A - 12 Months After Treatment. | 1.2 ratio | Standard Deviation 0.1 |
Comparison: Peak E of transmitral flow/ Peak A of transmitral flow (E/A).p-value: 0.5RepeatedMeasures ANOVA
Secondary
Assessment of Left Ventricular Diastolic Function - Peak E of Transmitral Flow and Peak А of Transmitral Flow 12 Months After Treatment.
Evaluation of left ventricular diastolic function (echocardiography). The peak velocity E reflects the pressure gradient between the LA and LV in early diastole, and it is affected by preload and disturbance LV relaxation The speed of peak A, which forms at the end diastole, influences LV compliance and contractility left atrium.
Time frame: 12 months after treatment.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Assessment of Left Ventricular Diastolic Function - Peak E of Transmitral Flow and Peak А of Transmitral Flow 12 Months After Treatment. | Peak E of transmitral flow | 0.7 meters/sec. | Standard Deviation 0.04 |
| Group 0 | Assessment of Left Ventricular Diastolic Function - Peak E of Transmitral Flow and Peak А of Transmitral Flow 12 Months After Treatment. | Peak А of transmitral flow | 0.7 meters/sec. | Standard Deviation 0.09 |
| Group 1 | Assessment of Left Ventricular Diastolic Function - Peak E of Transmitral Flow and Peak А of Transmitral Flow 12 Months After Treatment. | Peak E of transmitral flow | 0.7 meters/sec. | Standard Deviation 0.05 |
| Group 1 | Assessment of Left Ventricular Diastolic Function - Peak E of Transmitral Flow and Peak А of Transmitral Flow 12 Months After Treatment. | Peak А of transmitral flow | 07 meters/sec. | Standard Deviation 0.1 |
| Group 2 | Assessment of Left Ventricular Diastolic Function - Peak E of Transmitral Flow and Peak А of Transmitral Flow 12 Months After Treatment. | Peak E of transmitral flow | 0.8 meters/sec. | Standard Deviation 0.05 |
| Group 2 | Assessment of Left Ventricular Diastolic Function - Peak E of Transmitral Flow and Peak А of Transmitral Flow 12 Months After Treatment. | Peak А of transmitral flow | 0.8 meters/sec. | Standard Deviation 0.1 |
Comparison: Peak E of transmitral flowp-value: 0.35RepeatedMeasures ANOVA
Comparison: Peak A of transmitral flow.p-value: 0.7RepeatedMeasures ANOVA
Secondary
Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment.
1. functional class - The usual load does not cause changes in the state of health. Painful attacks occur against the background of excessive loads - after climbing several flights of stairs, while walking fast. 2. functional class - Pain attacks when walking more than 500 meters, when climbing stairs more than one floor. 3. functional class - The patient does not tolerate minimal physical activity. An attack occurs when walking a distance of 50-100 meters. Climbing stairs is difficult. 4. functional class - Activity is significantly limited. Angina pectoris manifests itself when performing minimal actions, including at rest.
Time frame: up to 12 months
Population: Data analysis of all patients underwent follow-up examination 12 months after surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 0 | Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | 3 functional class of angina pectoris1 year after | 0 participants |
| Group 0 | Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | 1 functional class of angina pectoris1 year after | 15 participants |
| Group 0 | Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | 4 functional class of angina pectoris1 year after | 0 participants |
| Group 0 | Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | 2 functional class of angina pectoris1 year after | 7 participants |
| Group 1 | Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | 3 functional class of angina pectoris1 year after | 0 participants |
| Group 1 | Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | 2 functional class of angina pectoris1 year after | 0 participants |
| Group 1 | Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | 4 functional class of angina pectoris1 year after | 0 participants |
| Group 1 | Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | 1 functional class of angina pectoris1 year after | 4 participants |
| Group 2 | Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | 4 functional class of angina pectoris1 year after | 0 participants |
| Group 2 | Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | 1 functional class of angina pectoris1 year after | 5 participants |
| Group 2 | Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | 2 functional class of angina pectoris1 year after | 0 participants |
| Group 2 | Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment. | 3 functional class of angina pectoris1 year after | 0 participants |
p-value: 0.001Chi-squared
Secondary
Distance Traveled in the 6-minute Walk Test. Test Results With 6 Minute Walk
The dynamic of the number of meters walked according to the 6-minutes walk test (6MWD) in the observation groups.
Time frame: initially and after 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Distance Traveled in the 6-minute Walk Test. Test Results With 6 Minute Walk | Original number of meters. | 315.06 meters | Standard Deviation 17.6 |
| Group 0 | Distance Traveled in the 6-minute Walk Test. Test Results With 6 Minute Walk | Number of meters in 12 months. | 433.54 meters | Standard Deviation 20.6 |
| Group 1 | Distance Traveled in the 6-minute Walk Test. Test Results With 6 Minute Walk | Original number of meters. | 319.8 meters | Standard Deviation 24.5 |
| Group 1 | Distance Traveled in the 6-minute Walk Test. Test Results With 6 Minute Walk | Number of meters in 12 months. | 524.4 meters | Standard Deviation 28.7 |
| Group 2 | Distance Traveled in the 6-minute Walk Test. Test Results With 6 Minute Walk | Original number of meters. | 329.9 meters | Standard Deviation 25.3 |
| Group 2 | Distance Traveled in the 6-minute Walk Test. Test Results With 6 Minute Walk | Number of meters in 12 months. | 452.7 meters | Standard Deviation 29.7 |
p-value: 0.0367Kruskal-Wallis
Secondary
Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency.
1. functional class - There is no limitation of a person's physical activity, shortness of breath manifests itself when going above the third floor. 2. functional class - slight limitation of activity, palpitations, shortness of breath, fatigue occur during normal physical activity and more. 3. functional class - Symptoms occur with the smallest physical activity, resulting in a significant decrease in activity. At rest, clinical manifestations are not observed. The smaller the functional class, the better the quality of human life.
Time frame: Assessment of the dynamics at 12 months after treatment.
Population: In one case, a patient of Groups 1 through 12 months after the treatment, marked progression of the functional class of heart failure. It should be noted that this patient did not adhere to the recommendations on lifestyle and drug therapy in the postoperative period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 0 | Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. | 3 functional class heart failure (NYHA). | 0 Participants |
| Group 0 | Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. | 2 functional class heart failure (NYHA). | 25 Participants |
| Group 0 | Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. | 1 functional class heart failure (NYHA). | 12 Participants |
| Group 1 | Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. | 3 functional class heart failure (NYHA). | 1 Participants |
| Group 1 | Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. | 1 functional class heart failure (NYHA). | 14 Participants |
| Group 1 | Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. | 2 functional class heart failure (NYHA). | 10 Participants |
| Group 2 | Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. | 3 functional class heart failure (NYHA). | 0 Participants |
| Group 2 | Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. | 1 functional class heart failure (NYHA). | 7 Participants |
| Group 2 | Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency. | 2 functional class heart failure (NYHA). | 15 Participants |
p-value: 0.13Chi-squared
Secondary
Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency.
Evaluation of myocardial contractility according to echocardiography, in particular the size of the left ventricle - the index was carried out 12 months after CABG. The higher the indicator (left ventricular size - index), the worse the prognosis of an unfavorable outcome. The index is used as an indicator of the payment to obtain a more reliable result (taking into account individual characteristics of each patient). index - size of the left ventricle (mm.)/ body mass index (kg/m\^2).
Time frame: 12 months after the treatment.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | Lvs ind. | 1.9 mm/m^2 | Standard Deviation 0.06 |
| Group 0 | Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | Lvd ind. | 2.7 mm/m^2 | Standard Deviation 0.07 |
| Group 0 | Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | LAind. | 2.2 mm/m^2 | Standard Deviation 0.05 |
| Group 1 | Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | Lvs ind. | 2.07 mm/m^2 | Standard Deviation 0.08 |
| Group 1 | Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | Lvd ind. | 2.9 mm/m^2 | Standard Deviation 0.08 |
| Group 1 | Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | LAind. | 2.3 mm/m^2 | Standard Deviation 0.07 |
| Group 2 | Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | Lvd ind. | 2.8 mm/m^2 | Standard Deviation 0.09 |
| Group 2 | Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | LAind. | 2.2 mm/m^2 | Standard Deviation 0.07 |
| Group 2 | Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | Lvs ind. | 1.8 mm/m^2 | Standard Deviation 0.08 |
Comparison: Lvd ind. (Lvd mm./BSA) - left ventricular end-diastolic size index. All patients included in the study.p-value: 0.2RepeatedMeasures ANOVA
Comparison: Lvs ind. (Lvs mm./BSA kg / cm) - left ventricular end-systolic size index.p-value: 0.2RepeatedMeasures ANOVA
Comparison: LAind. (LA mm./BSA kg / cm) - left atrial index.p-value: 0.5RepeatedMeasures ANOVA
Secondary
Estimation of the Index of Volumetric Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency.
Evaluation of myocardial contractility according to echocardiography, in particular the volume of the left ventricle - the index was carried out 12 months after CABG. The higher the indicator (left ventricular volume - index), the worse the prognosis of an unfavorable outcome. The index is used as an indicator of the payment to obtain a more reliable result (taking into account individual characteristics of each patient). index - volume of the left ventricle (mm.)/ body mass index (kg/m\^2).
Time frame: 12 Months After the Treatment
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Estimation of the Index of Volumetric Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | LVEDV MOD BP ind. | 62.3 mL/m^2 | Standard Deviation 4.4 |
| Group 0 | Estimation of the Index of Volumetric Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | LVESV MOD BP ind. | 25.2 mL/m^2 | Standard Deviation 2.6 |
| Group 1 | Estimation of the Index of Volumetric Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | LVEDV MOD BP ind. | 70.4 mL/m^2 | Standard Deviation 6.2 |
| Group 1 | Estimation of the Index of Volumetric Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | LVESV MOD BP ind. | 31.5 mL/m^2 | Standard Deviation 3.9 |
| Group 2 | Estimation of the Index of Volumetric Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | LVEDV MOD BP ind. | 66.9 mL/m^2 | Standard Deviation 5.5 |
| Group 2 | Estimation of the Index of Volumetric Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency. | LVESV MOD BP ind. | 25.6 mL/m^2 | Standard Deviation 3.5 |
Comparison: LVEDV MOD BP ind. (LVEDV MOD BP ml./BSA kg / cm) - left ventricular end-diastolic volume index.p-value: 0.6RepeatedMeasures ANOVA
Comparison: LVESV MOD BP ind. (LVESV MOD BP ml./BSA kg / cm) - left ventricular end-systolic volume index.p-value: 0.2RepeatedMeasures ANOVA
Secondary
Evaluation of the Left Ventricular Ejection Fraction 12 Months After Treatment.
According to echocardiography.
Time frame: 12 months after treatment.
Population: All patients included in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 0 | Evaluation of the Left Ventricular Ejection Fraction 12 Months After Treatment. | 61.4 percent | Standard Deviation 1.5 |
| Group 1 | Evaluation of the Left Ventricular Ejection Fraction 12 Months After Treatment. | 58.1 percent | Standard Deviation 1.8 |
| Group 2 | Evaluation of the Left Ventricular Ejection Fraction 12 Months After Treatment. | 58.4 percent | Standard Deviation 1.9 |
p-value: 0.35RepeatedMeasures ANOVA
Secondary
Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency.
The SF-36 questionnaire. The indicators of each scale vary between 0 and 100, where 100 represents total health. The results are presented in the form of scores on 8 scales, compiled in such a way that a higher score indicates a higher level of quality of life.MHFLQ - for patients with heart failure.The specified questionnaire consists of 21 questions. To answer each question, a scale of 6 points from the minimum intensity of certain symptoms to the maximum is used. The assessment is based on the sum of points, where the maximum number of points - 105 corresponds to the patient's worst condition. The lowest score 0 points is the best clinical condition of the patient. SAQ consists of 19 questions about the patient's condition, which are divided into the following 5 scales. The quality of life for each of the five scales under consideration is measured in percent, with 0% corresponding to the worst quality of life, and 100% to the best.
Time frame: At baseline and after one year.
Population: All patients included in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireAngina frequency | 48.7 score on a scale | Standard Deviation 5.7 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaire Disease perception/ in year | 60.7 score on a scale | Standard Deviation 24.4 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaiAngina frequency / in year | 80.3 score on a scale | Standard Deviation 4.2 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Vitality SF-36 | 52.6 score on a scale | Standard Deviation 3.7 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireTreatment satisfaction | 58.9 score on a scale | Standard Deviation 3.7 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Seattle QuestionnairePhysical limitation | 39.6 score on a scale | Standard Deviation 3.5 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | General Health SF-36 in year | 52.4 score on a scale | Standard Deviation 2.4 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Physical Functioning SF-36 | 48.6 score on a scale | Standard Deviation 4.6 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Social Functioning SF-36 | 66.4 score on a scale | Standard Deviation 4.2 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | General Health SF-36 | 48.6 score on a scale | Standard Deviation 2.5 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaire Disease perception | 41.4 score on a scale | Standard Deviation 4.3 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Physical Functioning SF-36 in year | 62.9 score on a scale | Standard Deviation 4 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Role-Physical Functioning SF-36 | 24.2 score on a scale | Standard Deviation 6.2 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Minnesota Quality of Life (MHFLQ) | 39.8 score on a scale | Standard Deviation 3.6 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Social Functioning SF-36 in year | 77.8 score on a scale | Standard Deviation 3.9 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Bodily pain SF-36 | 50.9 score on a scale | Standard Deviation 4.9 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Role-Physical Functioning SF-36 in year | 38.7 score on a scale | Standard Deviation 7.4 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Mental Health SF-36 in year | 64.5 score on a scale | Standard Deviation 2.9 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Mental Health SF-36 | 60.6 score on a scale | Standard Deviation 3.1 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Minnesota Quality of Life (MHFLQ) in year | 31.6 score on a scale | Standard Deviation 2.9 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnairePhysical limitation / in year | 53.5 score on a scale | Standard Deviation 2.9 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireTreatmentSatisfaction/ in year | 75.2 score on a scale | Standard Deviation 3.2 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Role- Emotional SF-36 in year | 58.6 score on a scale | Standard Deviation 7.6 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireAngina stability | 43.5 score on a scale | Standard Deviation 6.3 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Bodily pain SF-36 in year | 68 score on a scale | Standard Deviation 4.5 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Role- Emotional SF-36 | 51.5 score on a scale | Standard Deviation 7.2 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireAngina stability / in year | 87 score on a scale | Standard Deviation 7.1 |
| Group 0 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Vitality SF-36 in year | 61.3 score on a scale | Standard Deviation 2.6 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Bodily pain SF-36 in year | 75.8 score on a scale | Standard Deviation 6.04 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Role-Physical Functioning SF-36 in year | 41.7 score on a scale | Standard Deviation 10 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Bodily pain SF-36 | 53.3 score on a scale | Standard Deviation 6.7 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Vitality SF-36 in year | 67.2 score on a scale | Standard Deviation 3.6 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Social Functioning SF-36 | 65.9 score on a scale | Standard Deviation 5.7 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Role- Emotional SF-36 | 40.7 score on a scale | Standard Deviation 9.7 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Role- Emotional SF-36 in year | 53.7 score on a scale | Standard Deviation 10.2 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnairePhysical limitation / in year | 60.8 score on a scale | Standard Deviation 4.4 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireAngina stability | 40.4 score on a scale | Standard Deviation 9.7 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireAngina frequency | 48.5 score on a scale | Standard Deviation 8.8 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireTreatment satisfaction | 72.1 score on a scale | Standard Deviation 5.8 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Physical Functioning SF-36 | 47.8 score on a scale | Standard Deviation 6.2 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Physical Functioning SF-36 in year | 69.2 score on a scale | Standard Deviation 5.4 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Role-Physical Functioning SF-36 | 20.8 score on a scale | Standard Deviation 8.4 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | General Health SF-36 | 50.1 score on a scale | Standard Deviation 3.4 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | General Health SF-36 in year | 53.2 score on a scale | Standard Deviation 3.3 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Vitality SF-36 | 54.7 score on a scale | Standard Deviation 4.9 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Social Functioning SF-36 in year | 77.08 score on a scale | Standard Deviation 5.2 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Mental Health SF-36 | 64.9 score on a scale | Standard Deviation 4.2 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Mental Health SF-36 in year | 70 score on a scale | Standard Deviation 3.98 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Minnesota Quality of Life (MHFLQ) | 35.1 score on a scale | Standard Deviation 4.9 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Minnesota Quality of Life (MHFLQ) in year | 22.7 score on a scale | Standard Deviation 3.9 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Seattle QuestionnairePhysical limitation | 42.6 score on a scale | Standard Deviation 5.4 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireAngina stability / in year | 91.9 score on a scale | Standard Deviation 10.9 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaiAngina frequency / in year | 90.8 score on a scale | Standard Deviation 6.6 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireTreatmentSatisfaction/ in year | 81.3 score on a scale | Standard Deviation 4.9 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaire Disease perception | 36.5 score on a scale | Standard Deviation 6.7 |
| Group 1 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaire Disease perception/ in year | 64.2 score on a scale | Standard Deviation 20.8 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireAngina stability | 61 score on a scale | Standard Deviation 9.4 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Role- Emotional SF-36 | 38.3 score on a scale | Standard Deviation 9.7 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnairePhysical limitation / in year | 58.6 score on a scale | Standard Deviation 4.3 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Minnesota Quality of Life (MHFLQ) | 33.3 score on a scale | Standard Deviation 4.9 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaire Disease perception | 37.9 score on a scale | Standard Deviation 6.5 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Mental Health SF-36 | 67.5 score on a scale | Standard Deviation 4.2 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Role- Emotional SF-36 in year | 55.5 score on a scale | Standard Deviation 10.2 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Bodily pain SF-36 | 57.8 score on a scale | Standard Deviation 6.7 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Mental Health SF-36 in year | 72.7 score on a scale | Standard Deviation 3.98 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Social Functioning SF-36 | 66.3 score on a scale | Standard Deviation 5.7 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Role-Physical Functioning SF-36 | 21 score on a scale | Standard Deviation 8.4 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireTreatmentSatisfaction/ in year | 80.4 score on a scale | Standard Deviation 4.8 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Minnesota Quality of Life (MHFLQ) in year | 22.1 score on a scale | Standard Deviation 3.9 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Vitality SF-36 in year | 64.7 score on a scale | Standard Deviation 3.6 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Physical Functioning SF-36 in year | 68.6 score on a scale | Standard Deviation 5.4 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Bodily pain SF-36 in year | 73.4 score on a scale | Standard Deviation 6.04 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Physical Functioning SF-36 | 51.1 score on a scale | Standard Deviation 6.2 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Role-Physical Functioning SF-36 in year | 43.06 score on a scale | Standard Deviation 10 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | General Health SF-36 | 45 score on a scale | Standard Deviation 3.4 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireTreatment satisfaction | 69.6 score on a scale | Standard Deviation 5.6 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Seattle QuestionnairePhysical limitation | 40 score on a scale | Standard Deviation 5.2 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | General Health SF-36 in year | 53.5 score on a scale | Standard Deviation 3.3 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaiAngina frequency / in year | 86.4 score on a scale | Standard Deviation 6.3 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaire Disease perception/ in year | 64.3 score on a scale | Standard Deviation 20.1 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Vitality SF-36 | 53.8 score on a scale | Standard Deviation 4.9 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireAngina stability / in year | 98.2 score on a scale | Standard Deviation 10.6 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | SeattleQuestionnaireAngina frequency | 46.07 score on a scale | Standard Deviation 8.5 |
| Group 2 | Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency. | Social Functioning SF-36 in year | 82.6 score on a scale | Standard Deviation 5.2 |
Comparison: Physical Functioning SF-36. Comparison of patients of group 1 and group 2 with the control group - group 0.p-value: 0.7RepeatedMeasures ANOVA
Comparison: Role-Physical Functioning SF-36p-value: 0.8RepeatedMeasures ANOVA
Comparison: Bodily pain SF-36p-value: 0.7RepeatedMeasures ANOVA
Comparison: General Health SF-36.p-value: 0.6RepeatedMeasures ANOVA
Comparison: Vitality SF-36.p-value: 0.8RepeatedMeasures ANOVA
Comparison: Social Functioning SF-36.p-value: 0.7RepeatedMeasures ANOVA
Comparison: Role- Emotional SF-36.p-value: 0.7RepeatedMeasures ANOVA
Comparison: Mental Health SF-36.p-value: 0.96RepeatedMeasures ANOVA
Comparison: Minnesota Quality of Life (MHFLQ).p-value: 0.7RepeatedMeasures ANOVA
Comparison: Seattle QuestionnairePhysical limitation.p-value: 0.6RepeatedMeasures ANOVA
Comparison: SeattleQuestionnaireAngina stability.p-value: 0.4RepeatedMeasures ANOVA
Comparison: SeattleQuestionnaireAngina frequency.p-value: 0.6RepeatedMeasures ANOVA
Comparison: SeattleQuestionnaireTreatment satisfaction.p-value: 0.7RepeatedMeasures ANOVA
Comparison: SeattleQuestionnaire Disease perception.p-value: 0.3RepeatedMeasures ANOVA
Secondary
The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography).
According to the angiographic study.
Time frame: up to 12 months
Population: All patients included in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 0 | The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). | Number of functioning grafts at 12 months | 99 Number of grafts |
| Group 0 | The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). | Initial number of grafts | 113 Number of grafts |
| Group 0 | The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). | Number of non-functioning grafts after 12 months | 14 Number of grafts |
| Group 1 | The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). | Number of functioning grafts at 12 months | 76 Number of grafts |
| Group 1 | The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). | Initial number of grafts | 79 Number of grafts |
| Group 1 | The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). | Number of non-functioning grafts after 12 months | 3 Number of grafts |
| Group 2 | The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). | Initial number of grafts | 75 Number of grafts |
| Group 2 | The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). | Number of non-functioning grafts after 12 months | 2 Number of grafts |
| Group 2 | The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography). | Number of functioning grafts at 12 months | 73 Number of grafts |
Comparison: Assessment of the functioning of grafts. Patency of grafts within a specified time of treatment (angiography).p-value: 0.04Chi-squared
Other Pre-specified
Smoking as a Factor That Negatively Affects the Results of the Test With a 6-minute Walk in Dynamics.
The distance covered (in meters) was compared with the proper value depending on age (years), height (cm), weight (kg), body mass index (BMI). The due values (6MWD (i)) were calculated using the following formulas: For men: 6МWD (i) = 7.57 × height - 5.02 × age - 1.76 × weight - 309 or 6MWD (i) = 1140 - 5.61 × BMI - 6.94 × age. For women: 6МWD (i) = 2.11 × height - 2.29 × weight - 5.78 × age + 667 Or 6МWD (i) = 1017 - 6.24 × BMI - 5.83 × age. This difference at baseline is reported as distance walked for smokers minus non-smokers.
Time frame: 12 months after treatment.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | Smoking as a Factor That Negatively Affects the Results of the Test With a 6-minute Walk in Dynamics. | diference between smokers and non-smoking participants at baseline | 230.04 meters | Standard Deviation 28.7 |
| Group 0 | Smoking as a Factor That Negatively Affects the Results of the Test With a 6-minute Walk in Dynamics. | diference between baseline and1 year after surgery | 87.9 meters | Standard Deviation 4.9 |
| Group 1 | Smoking as a Factor That Negatively Affects the Results of the Test With a 6-minute Walk in Dynamics. | diference between smokers and non-smoking participants at baseline | 215.3 meters | Standard Deviation 31.4 |
| Group 1 | Smoking as a Factor That Negatively Affects the Results of the Test With a 6-minute Walk in Dynamics. | diference between baseline and1 year after surgery | 8.5 meters | Standard Deviation 2.7 |
| Group 2 | Smoking as a Factor That Negatively Affects the Results of the Test With a 6-minute Walk in Dynamics. | diference between smokers and non-smoking participants at baseline | 224.8 meters | Standard Deviation 27.1 |
| Group 2 | Smoking as a Factor That Negatively Affects the Results of the Test With a 6-minute Walk in Dynamics. | diference between baseline and1 year after surgery | 62.1 meters | Standard Deviation 4.8 |
Comparison: Factor analysis - determining the influence of a factor, in this case, smoking, on the deficit in the number of meters passed according to the test with a 6-minute walk.p-value: 0.046Factor analysis
Other Pre-specified
The Amount of Cell Material (Percentage).
Dependence and duration of positive clinical effect on the amount of injected cell material (Mononuclear fraction %, CD34+ %, CD133+ %). Assessment - mononuclear fraction, CD 34 +, CD 133+ according to flow cytometry data.
Time frame: Initial data at the time of collection of bone marrow cells.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 0 | The Amount of Cell Material (Percentage). | CD133+/ % | 0.4 percent | Standard Deviation 0.08 |
| Group 0 | The Amount of Cell Material (Percentage). | Mononuclear fraction/ % | 21.04 percent | Standard Deviation 2.9 |
| Group 0 | The Amount of Cell Material (Percentage). | CD34+/ % | 1.16 percent | Standard Deviation 0.22 |
| Group 1 | The Amount of Cell Material (Percentage). | CD133+/ % | 0.38 percent | Standard Deviation 1.14 |
| Group 1 | The Amount of Cell Material (Percentage). | Mononuclear fraction/ % | 20.0 percent | Standard Deviation 2.7 |
| Group 1 | The Amount of Cell Material (Percentage). | CD34+/ % | 1.18 percent | Standard Deviation 0.34 |
Comparison: Mononuclear fraction %p-value: 0.05Discriminant Analysis
Comparison: CD34+ %p-value: 0.057Discriminant Analysis
Comparison: CD133+ %p-value: 0.05Discriminant Analysis
Other Pre-specified
The Volume of Cellular Material (Cytosis).
Dependence and Duration of Positive Clinical Effect on the Amount of Injected Cell Material (cytosis).
Time frame: Initial data at the time of collection of bone marrow cells.
Population: The data of all patients initially included in the study were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 0 | The Volume of Cellular Material (Cytosis). | 20.3 *10^8cells/l | Standard Deviation 8.9 |
| Group 1 | The Volume of Cellular Material (Cytosis). | 20.3 *10^8cells/l | Standard Deviation 8.9 |
p-value: 0.05Discriminant Analysis