"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
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Heart Failure
Procedure: PCI and Stem Cells or Placebo injections
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • Reduction in left ventricle systolic volume on 15% mesured by MRI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: November 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1 (PCI+SC implantation)
Endocardial Stem cells implantation with Noga system
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.
Placebo Comparator: Group 2 (PCI+Placebo)
Placebo
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394432

Contacts
Contact: Evgeny Pokushalov, MD +79139254858 E.Pokushalov@gmail.com
Contact: Alexander Romanov, MD +79137172652 abromanov@mail.ru

Locations
Russian Federation
State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Evgeny Pokushalov, MD    +79139254858    E.Pokushalov@gmail.com   
Contact: Alexander Romanov, MD    +79137172652    abromanov@mail.ru   
Principal Investigator: Evgeny Pokushalov, MD, PhD         
Sub-Investigator: Alexander Romanov, MD, PhD         
Sub-Investigator: Igor Grazhdankin, MD         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Evgeny A Pokushalov, MD, PhD State Research Institute of Circulation Pathology
  More Information

No publications provided

Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01394432     History of Changes
Other Study ID Numbers: RBI-1749, RU8HM86-54N
Study First Received: July 8, 2011
Last Updated: July 4, 2013
Health Authority: Russia: Ethics Committee

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Endocardial Stem Cells Injection
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014