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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02059512
Recruitment Status : Unknown
Verified December 2016 by St. Petersburg State Pavlov Medical University.
Recruitment status was:  Active, not recruiting
First Posted : February 11, 2014
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
St. Petersburg State Pavlov Medical University

Tracking Information
First Submitted Date  ICMJE February 1, 2014
First Posted Date  ICMJE February 11, 2014
Last Update Posted Date September 28, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
All-cause mortality associated with the progression of basic disease [ Time Frame: up to 60 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
Quality of life [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 13, 2016)
Percentage of functioning grafts in patients with implantation of autologous bone marrow mononuclear cells. [ Time Frame: up to 60 months ]
Estimation of efficiency:
  1. Assessment of myocardial perfusion and metabolism (before and after treatment).
  2. Evaluation of systolic and diastolic myocardial function.
  3. Speckle tracking echocardiography
  4. Patency of grafts within a specified time of treatment (angiography).
  5. Dependence and duration of positive clinical effect on the amount of injected cell material.
  6. Evaluation of the quality of life (Minnesota questionnaire, Seattle questionnaire, SF-36 questionnaire).
Original Other Pre-specified Outcome Measures
 (submitted: February 10, 2014)
Percentage of functioning grafts in patients with implantation of autologous bone marrow mononuclear cells. [ Time Frame: up to 60 months ]
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Mononuclear Cells in the Combined Treatment of Coronary Heart Disease
Official Title  ICMJE 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
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).
Detailed Description

Additional estimation of safety:

  1. Assessment of EuroScore II.
  2. The duration of stay in the intensive care unit.
  3. Restoration of cardiac rhythm at the end of the main stage of operation (defibrillation / self-recovery).
  4. The time of extracorporeal circulation.
  5. Time of anoxia.
  6. The amount of blood loss by drainage in the 1st day.
  7. The amount of discharge during the second day.
  8. Troponin I at 1, 2, 3 postoperative days.
  9. Postoperative complications (hydrothorax, hydropericardium, arrhythmias).

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 +.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Heart Disease
Intervention  ICMJE
  • Procedure: coronary artery bypass grafting with administration of autologous bone marrow stem cells
  • Procedure: coronary artery bypass grafting with administration of 0.9 % NaCl (sodium chloride) 0.2 ml
Study Arms  ICMJE
  • Active Comparator: cell Therapy 1
    intramyocardial administration of autologous bone marrow mononuclear cells during the operation coronary artery bypass grafting
    Intervention: Procedure: coronary artery bypass grafting with administration of autologous bone marrow stem cells
  • Placebo Comparator: non cell therapy
    intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml
    Intervention: Procedure: coronary artery bypass grafting with administration of 0.9 % NaCl (sodium chloride) 0.2 ml
  • Active Comparator: cell therapy 2
    intramyocardial and intracoronary administration of autologous bone marrow mononuclear cells during coronary artery bypass grafting
    Intervention: Procedure: coronary artery bypass grafting with administration of autologous bone marrow stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 10, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women from 18 to 80 years
  • Patients with angina pectoris III-IV functional class
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02059512
Other Study ID Numbers  ICMJE NBK-2901-AMNKM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party St. Petersburg State Pavlov Medical University
Study Sponsor  ICMJE St. Petersburg State Pavlov Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vladimir V Komok First Pavlov State Medical University of St. Petersburg.
PRS Account St. Petersburg State Pavlov Medical University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP