Autologous Bone Marrow Mononuclear Cells in the Combined Treatment of Coronary Heart Disease (TAMIS)

St. Petersburg State Pavlov Medical University

Status: Completed

Conditions: Coronary Artery Bypass Grafting (CABG); Ischemic Heart Disease; Heart Failure, Diastolic; Bone Marrow Cells

Treatments: Procedure: Group 0; Procedure: Group 1; Procedure: Group 2

Study type: Interventional

Funder types: Other

Identifiers

NCT02059512

NBK-2901-AMNKM

Details and patient eligibility

About

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).

Full 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 +.

Enrollment: 117 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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117 participants in 3 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

Intramyocardial administration of autologous bone marrow mononuclear cells during the operation coronary artery bypass grafting 0.2 ml - 10 injection in the zone of blood supply LAD.

Treatment:

Procedure: Group 1

Group 0

Placebo Comparator group

Description:

Intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD during the operation coronary artery bypass grafting.

Treatment:

Procedure: Group 0

Group 2

Active Comparator group

Description:

Intramyocardial and intracoronary administration of autologous bone marrow mononuclear cells during coronary artery bypass grafting intramyocardial 0.2 ml - 10 injection in the zone of blood supply LAD.

Treatment:

Procedure: Group 2