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"ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction (ESTIMATION)

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ClinicalTrials.gov Identifier: NCT01394432
Recruitment Status : Unknown
Verified September 2015 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : July 14, 2011
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

Tracking Information
First Submitted Date  ICMJE July 8, 2011
First Posted Date  ICMJE July 14, 2011
Last Update Posted Date September 23, 2015
Study Start Date  ICMJE July 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2011)
Reduction in left ventricle systolic volume on 15% mesured by MRI [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2011)
  • All-cause death [ Time Frame: 12 months ]
  • number of patients with thromboembolic events [ Time Frame: 12 months ]
    comparison the number of patients with thromboembolic events between two groups
  • number of heart failure hospitalizations [ Time Frame: 12 months ]
  • Distance during 6-minute walking test [ Time Frame: 12 months ]
  • number of patients with life-threatening arrhythmias [ Time Frame: 12 months ]
  • BNP level [ Time Frame: 12 months ]
  • SPECT and Echo data [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE "ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
Official Title  ICMJE Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
Brief Summary The investigators hypothesised that endocardial stem cells implantation following after percutaneous coronary intervention (PCI) could reduce the scar formation and increase reverse remodeling in patients with primary acute myocardial infarction.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myocardial Infarction
  • Heart Failure
Intervention  ICMJE Procedure: PCI and Stem Cells or Placebo injections
Conventional percutaneous coronary intervention after acute myocardial infarction. Harvest of bone marrow from iliac crest. Mesenchymal autologous stem cells preparation (7-10 days after PCI). LV mapping with Noga system (7-10 days after PCI). Randomization 1:1. Stem Cells or placebo implantation.
Study Arms  ICMJE
  • Active Comparator: Group 1 (PCI+SC implantation)
    Endocardial Stem cells implantation with Noga system
    Intervention: Procedure: PCI and Stem Cells or Placebo injections
  • Placebo Comparator: Group 2 (PCI+Placebo)
    Placebo
    Intervention: Procedure: PCI and Stem Cells or Placebo injections
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: July 13, 2011)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with acute Q-wave myocardial infarction after thrombolitic therapy during 6-36 hours from the onsent of signs
  • Oclusion or significant stenosis of infarct-related left anterior descending artery (LAD)
  • Left ventricle ejection fraction (LVEF) < 50% measured by Echo

Exclusion Criteria:

  • Thrombolysis of pyrrolase or streptokinase
  • Surgical unsignificant stenosis of LAD
  • Indications for CABG
  • Cardiogenic shock
  • Uncontrolled hypertension
  • Thrombocytopenia
  • Ongoing bleeding
  • Anemia < 100 g/l
  • Oncology
  • Patients, who required anticoagulation therapy at the time of inclusion
  • Obesity, BMI>40
  • Severe comorbidities
  • Unwillingness to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 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 NCT01394432
Other Study ID Numbers  ICMJE RBI-1749
RU8HM86-54N ( Other Identifier: State Research Institute of Circulation Pathology )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meshalkin Research Institute of Pathology of Circulation
Study Sponsor  ICMJE Meshalkin Research Institute of Pathology of Circulation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Evgeny A Pokushalov, MD, PhD State Research Institute of Circulation Pathology
PRS Account Meshalkin Research Institute of Pathology of Circulation
Verification Date September 2015

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