"ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
ESTIMATION
Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2011
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 8, 2011
CompletedFirst Posted
Study publicly available on registry
July 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedSeptember 23, 2015
September 1, 2015
1.3 years
July 8, 2011
September 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in left ventricle systolic volume on 15% mesured by MRI
12 months
Secondary Outcomes (7)
All-cause death
12 months
number of patients with thromboembolic events
12 months
number of heart failure hospitalizations
12 months
Distance during 6-minute walking test
12 months
number of patients with life-threatening arrhythmias
12 months
- +2 more secondary outcomes
Study Arms (2)
Group 1 (PCI+SC implantation)
ACTIVE COMPARATOREndocardial Stem cells implantation with Noga system
Group 2 (PCI+Placebo)
PLACEBO COMPARATORPlacebo
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
- Obesity, BMI\>40
- Severe comorbidities
- Unwillingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Research Institute of Circulation Pathology
Novosibirsk, 630055, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evgeny A Pokushalov, MD, PhD
State Research Institute of Circulation Pathology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2011
First Posted
July 14, 2011
Study Start
July 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2016
Last Updated
September 23, 2015
Record last verified: 2015-09