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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Meshalkin Research Institute of Pathology of Circulation
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01394432
First received: July 8, 2011
Last updated: July 4, 2013
Last verified: July 2013

July 8, 2011
July 4, 2013
July 2011
November 2012   (final data collection date for primary outcome measure)
Reduction in left ventricle systolic volume on 15% mesured by MRI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01394432 on ClinicalTrials.gov Archive Site
  • All-cause death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • number of patients with thromboembolic events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    comparison the number of patients with thromboembolic events between two groups
  • number of heart failure hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Distance during 6-minute walking test [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • number of patients with life-threatening arrhythmias [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • BNP level [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • SPECT and Echo data [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
"ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Myocardial Infarction
  • Heart Failure
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
November 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact: Evgeny Pokushalov, MD +79139254858 E.Pokushalov@gmail.com
Contact: Alexander Romanov, MD +79137172652 abromanov@mail.ru
Russian Federation
 
NCT01394432
RBI-1749, RU8HM86-54N
Yes
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Principal Investigator: Evgeny A Pokushalov, MD, PhD State Research Institute of Circulation Pathology
Meshalkin Research Institute of Pathology of Circulation
July 2013

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