"ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
NCT ID: NCT01394432
Last Updated: 2015-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2011-07-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1 (PCI+SC implantation)
Endocardial Stem cells implantation with Noga system
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.
Group 2 (PCI+Placebo)
Placebo
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.
Interventions
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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 Criteria
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Inclusion Criteria
* Oclusion or significant stenosis of infarct-related left anterior descending artery (LAD)
* Left ventricle ejection fraction (LVEF) \< 50% measured by Echo
Exclusion Criteria
* 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
30 Years
75 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Principal Investigators
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Evgeny A Pokushalov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
State Research Institute of Circulation Pathology
Locations
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State Research Institute of Circulation Pathology
Novosibirsk, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RU8HM86-54N
Identifier Type: OTHER
Identifier Source: secondary_id
RBI-1749
Identifier Type: -
Identifier Source: org_study_id
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