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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 3

Conditions: Heart Failure; Acute Myocardial Infarction

Treatments: Procedure: PCI and Stem Cells or Placebo injections

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01394432

RBI-1749

RU8HM86-54N (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Group 1 (PCI+SC implantation)

Active Comparator group

Description:

Endocardial Stem cells implantation with Noga system

Treatment:

Procedure: PCI and Stem Cells or Placebo injections

Group 2 (PCI+Placebo)

Placebo Comparator group

Description:

Placebo

Treatment:

Procedure: PCI and Stem Cells or Placebo injections