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

Heart Failure Clinical Trial

— ESTIMATION  

Official title:

Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01394432
• Other study ID #: RBI-1749
• Secondary ID: RU8HM86-54N
• Status: Recruiting
• Phase: Phase 3
• First received: July 8, 2011
• Last updated: September 21, 2015
• Start date: July 2011
• Est. completion date: November 2016

Study information

• Verified date: September 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Evgeny Pokushalov, MD
• Phone: +79139254858
• Email: E.Pokushalov[@]gmail.com
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2016
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in left ventricle systolic volume on 15% mesured by MRI		12 months	Yes
Secondary	All-cause death		12 months	Yes
Secondary	number of patients with thromboembolic events	comparison the number of patients with thromboembolic events between two groups	12 months	Yes
Secondary	number of heart failure hospitalizations		12 months	Yes
Secondary	Distance during 6-minute walking test		12 months	Yes
Secondary	number of patients with life-threatening arrhythmias		12 months	Yes
Secondary	BNP level		12 months	Yes
Secondary	SPECT and Echo data		12 months	Yes

External Links

•   State Research Institute of Circulation Pathology Official Site