First Pavlov State Medical University of St. Petersburg
Saint Petersburg, 197089, Russia
NCT Number: NCT02059512
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).
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Saint Petersburg, 197089, Russia
Additional estimation of safety:
Estimation of efficiency:
Predicting the results of treatment (the effect of a number of parameters):
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: CABG with intramyocardial administration of ABMMC.
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.
Other names: CABG with administration of 0.9 % sodium chlorid.
Coronary artery bypass grafting with intramyocardial and intracoronary administration of autologous bone marrow mononuclear cells intramyocardial administration 0.2 ml - 10 injection in the zone of blood supply LAD.
Other names: CABG with intramyocardial and intracoronary administration of ABMMC.
Time frame: 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.
Time frame: Primary hospitalization for planned CABG.
The results were obtained from the analysis of primary data.
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.
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: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative data.
Time frame: 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.
Time frame: Postoperative period.
The presence of complications in the postoperative period (Hydrothorax, Hydropericardium, Cardiac arrhythmias - atrial fibrillation / atrial flutter).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 12 months
Time frame: Assessment of the dynamics at 12 months after treatment.
The smaller the functional class, the better the quality of human life.
Time frame: 12 months after treatment.
According to echocardiography.
Time frame: 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).
Time frame: 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).
Time frame: 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
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.
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: 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.
Time frame: up to 12 months
According to the angiographic study.
Time frame: up to 12 months
Echocardiographic data.
Time frame: 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).
Time frame: 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.
Time frame: 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.
St. Petersburg State Pavlov Medical University
Other
Influence of the Administration of Autologous Bone Marrow Mononuclear Cells for the Duration of Functioning Aorto-coronary Bypass Grafts in the Surgical Treatment of Coronary Heart Disease
Acronym: TAMIS
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