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临床试验/NCT02059512
NCT02059512已完成不适用

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

St. Petersburg State Pavlov Medical University2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
117
试验地点
2
主要终点
Intraoperative Assessment of Homeostasis (Hemoglobin (Hb).

研究概览

简要总结

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).

详细描述

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):

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Randomization into three observation groups was carried out according to the table of random numbers.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Intraoperative Assessment of Homeostasis (Hemoglobin (Hb).

时间窗: 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+).

时间窗: 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.

时间窗: Intraoperative data.

Left Ventricular Ejection Fraction - Echocardiography - Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety.

时间窗: 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.

Restoration of the Heart Rate After the Completion of the Main Stage of the Surgical Intervention. Additional Estimation of Safety.

时间窗: 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).

时间窗: 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.

Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)),

时间窗: 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.

Dynamics of Markers of Myocardial Damage (Creatine Phosphokinase Fraction MB (CPK-MB)).

时间窗: 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.

Length of Hospital Stay. Length of Stay in the Intensive Care Unit.

时间窗: 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).

时间窗: 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.

The Volume of Discharge Through the Drains in the Early Postoperative Period.

时间窗: 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).

时间窗: 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 of Aortic Clamping (Anoxia).

时间窗: 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.

时间窗: Postoperative period.

The presence of complications in the postoperative period (Hydrothorax, Hydropericardium, Cardiac arrhythmias - atrial fibrillation / atrial flutter).

Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety.

时间窗: 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).

Intraoperative Assessment of Homeostasis (Hematocrit (HCT)).

时间窗: 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.

Volume of the Left Ventricle - Index - Echocardiography. Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety.

时间窗: 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).

次要结局

  • Evaluation of the Left Ventricular Ejection Fraction 12 Months After Treatment.(12 months after treatment.)
  • All-cause Mortality Associated With the Progression of Basic Disease.(12 months after surgery)
  • 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.)
  • Assessment of Left Ventricular Diastolic Function - DT and IVRT 12 Months After Treatment.(12 Months After Treatment.)
  • The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography).(up to 12 months)
  • Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment.(up to 12 months)
  • Distance Traveled in the 6-minute Walk Test. Test Results With 6 Minute Walk(initially and after 12 months)
  • Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency.(12 months after the treatment.)
  • Estimation of the Index of Volumetric Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency.(12 Months After the Treatment)
  • 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.)
  • Assessment of Left Ventricular Diastolic Function E/A - 12 Months After Treatment.(12 months after treatment)
  • Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency.(Assessment of the dynamics at 12 months after treatment.)
  • Analysis of the Effect of Left Ventricular Diastolic Dysfunction on the Patency of the Grafts.(up to 12 months)

研究者

发起方
St. Petersburg State Pavlov Medical University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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