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

Phase 3

• Conditions: Heart Failure; Acute Myocardial Infarction
• Interventions: Procedure: PCI and Stem Cells or Placebo injections

• Registration Number: NCT01394432
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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 available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Primary Completion: 2012-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (PCI+SC implantation)	PCI and Stem Cells or Placebo injections	Endocardial Stem cells implantation with Noga system
Group 2 (PCI+Placebo)	PCI and Stem Cells or Placebo injections	Placebo

Primary Outcome Measures

Name	Time	Method
Reduction in left ventricle systolic volume on 15% mesured by MRI	12 months

Secondary Outcome Measures

Name	Time	Method
number of patients with life-threatening arrhythmias	12 months
SPECT and Echo data	12 months
number of patients with thromboembolic events	12 months	comparison the number of patients with thromboembolic events between two groups
number of heart failure hospitalizations	12 months
BNP level	12 months
All-cause death	12 months
Distance during 6-minute walking test	12 months

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation