N/A N=117 Randomized Single-blind Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT02059512 ↗

Enrolled (actual)

117

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Assessment of the Initial Risk of Surgery (EuroScore II). — 1.3; 1.07; 1.02 percent — p=0.24

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Group 1 (Procedure); Group 0 (Procedure); Group 2 (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: St. Petersburg State Pavlov Medical University
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Assessment of the Initial Risk of Surgery (EuroScore II).	1.3; 1.07; 1.02	0.24
PRIMARY Length of Hospital Stay. Length of Stay in the Intensive Care Unit.	36.8; 32.8; 38.4; 3.9; 3.1; 3.3	0.1
PRIMARY The Severity of the Systemic Inflammatory Response in the Postoperative Period (Leukocytosis).	8.3; 6.5; 7.3; 13.9; 14.1; 16.2	0.4
PRIMARY Assessment of the Degree of General Inflammatory Response (C-reactive Protein (CRP)),	4.4; 3.05; 5.1; 80.2; 85.9; 121.1	0.1
PRIMARY The Volume of Discharge Through the Drains in the Early Postoperative Period.	541.2; 424; 410; 189.7; 152; 195.4	0.2
PRIMARY Dynamics of Markers of Myocardial Damage (Troponin I, Myoglobin).	12.05; 5.7; 2.9; 19.6; 3.08; 1.9	0.6
PRIMARY Dynamics of Markers of Myocardial Damage (Creatine Phosphokinase Fraction MB (CPK-MB)).	62.3; 63.02; 78.6; 35.4; 9.5; 4.6	0.7
PRIMARY Intraoperative Assessment of Homeostasis (Hemoglobin (Hb).	74.05; 73.4; 75.8; 91.3; 91.5; 86.7	1.0
PRIMARY Intraoperative Assessment of Homeostasis (Hematocrit (HCT)).	23.4; 22.2; 23.2; 29.3; 27.8; 25.7	0.8
PRIMARY Intraoperative Assessment of Homeostasis (К+).	5.01; 5.4; 4.7; 3.9; 4.5; 3.9	0.4
PRIMARY Cardiopulmonary Bypass Time.	135; 122.8; 144	0.1
PRIMARY Time of Aortic Clamping (Anoxia).	75.8; 73.8; 84	0.1
PRIMARY Assessment of Complications in the Postoperative Period. Additional Estimation of Safety.	3; 4; 3; 0; 1; 2	0.6
PRIMARY Left Ventricular Ejection Fraction - Echocardiography - Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety.	62.1; 56.4; 55.9	0.4
PRIMARY Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment - Echocardiography (Size of the Left Ventricle - Index). Additional Estimation of Safety.	2.6; 3; 2.7; 1.8; 2.1; 1.9	0.5
PRIMARY Volume of the Left Ventricle - Index - Echocardiography. Assessment of Myocardial Contractility on Days 7-14 After Surgical Treatment. Additional Estimation of Safety.	58.8; 70.9; 63.9; 23.5; 31.9; 27.8	0.4
PRIMARY Restoration of the Heart Rate After the Completion of the Main Stage of the Surgical Intervention. Additional Estimation of Safety.	3; 3; 4	0.6
SECONDARY All-cause Mortality Associated With the Progression of Basic Disease.	0; 0; 0	—
SECONDARY Quality of Life. Evaluation of the Quality of Life (Minnesota Questionnaire (MHFLQ), Seattle Questionnaire (SAQ), SF-36 Questionnaire). Estimation of Efficiency.	48.6; 47.8; 51.1; 62.9; 69.2; 68.6	0.7
SECONDARY Assessment of the Functional Class of Exertional Angina at 12 Months After Surgical Treatment.	15; 4; 5; 7; 0; 0	0.001 sig
SECONDARY Dynamics of the Functional Class of Heart Failure (NYHA). Estimation of Efficiency.	12; 14; 7; 25; 10; 15	0.13
SECONDARY Evaluation of the Left Ventricular Ejection Fraction 12 Months After Treatment.	61.4; 58.1; 58.4	0.35
SECONDARY Estimation of the Index of Linear Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency.	2.7; 2.9; 2.8; 1.9; 2.07; 1.8	0.2
SECONDARY Estimation of the Index of Volumetric Parameters of the Left Ventricle 12 Months After the Treatment. Estimation of Efficiency.	62.3; 70.4; 66.9; 25.2; 31.5; 25.6	0.6
SECONDARY Assessment of Left Ventricular Diastolic Function - Peak E of Transmitral Flow and Peak А of Transmitral Flow 12 Months After Treatment.	0.7; 0.7; 0.8; 0.7; 07; 0.8	0.35
SECONDARY Assessment of Left Ventricular Diastolic Function E/A - 12 Months After Treatment.	1; 1.2; 1.2	0.5
SECONDARY Assessment of Left Ventricular Diastolic Function - DT and IVRT 12 Months After Treatment.	250.4; 252.6; 256.6; 96.9; 102.4; 99.6	0.9
SECONDARY Distance Traveled in the 6-minute Walk Test. Test Results With 6 Minute Walk	315.06; 319.8; 329.9; 433.54; 524.4; 452.7	0.0367 sig
SECONDARY The Number of Functioning Grafts 12 Months After CABG. Patency of Grafts Within a Specified Time of Treatment (Angiography).	113; 79; 75; 99; 76; 73	0.04 sig
SECONDARY Analysis of the Effect of Left Ventricular Diastolic Dysfunction on the Patency of the Grafts.	10; 1; 2; 8; 0; 1	0.05

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).

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02059512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.