• Occurrence of MACCE [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  MACCE is defined as major adverse cardiac and cerebrovascular events including re-AMI, TVR, all-cause death and stroke at the 5-year FUP of the patients enrolled into the MYSTAR study and underwent cardiac stem cell therapy.
  
  

• Breakpoint parameters of the primary endpoint MACCE [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  MACCE is defined as cardiac death, nonfatal myocardial infarction, TVR and stroke
  
  
• Occurrence of cardiac death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  
• - Incidence of hospitalization due to angina pectoris or acute heart failure [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  
• Incidence of implantation of implantable cardiac defibrillator (ICD) and/or pacemaker (PM) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  
• Increase in global LV EF, measured by cardiac MRI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  In patients where Cardiac-MRI is performed on a clinical routine basis: increase in global LV EF, measured by cardiac MRI
  
  
• Decrease in infarct size and stress-inducible myocardial ischemia measured by SPECT [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  

Background: Based on the available long-term results of cardiac stem cell therapies, it seems, that it offers short-term moderate benefits, but the long-term outcome is still matter of debate. In 2008, the Austrian arm of the MYSTAR study (a prospective multi-center single-blind trial) including patients with recent AMI and treated with combined (intramyocardial and intracoronary) delivery of autologous BM-MNCs has been completed with 1-year FUP. The MYSTAR results showed moderate but significant improvement in infarct size and LV function similar to other trials, and confirmed safety, feasibility and efficacy of BMC treatment in AMI patients. The patients enrolled in the study reach the 5 to 8 years FUP at 2011, raising the question whether the combined delivery of autologous BM-MNCs results in a long-term benefit for these patients.

Aim of the study: To investigate the long-term, 5 years clinical outcome of patients enrolled into the MYSTAR study.

Study design: Prospective non-randomized single-center Austrian long-term FUP registry.

Study patients: A total of 60 patients with previous cardiac stem cell therapy (participated in the MYSTAR study) will be included in the present study

Primary endpoint: Occurrence of MACCE, defined as major adverse cardiac and cerebrovascular events including re-infarction, target vessel revascularization, all-cause death and stroke at the 5-year FUP

Secondary endpoints:

• Breakpoint parameters of the primary endpoint MACCE, defined as cardiac death, nonfatal myocardial infarction, TVR and stroke during the 2, 3, 4 and 5 years FUP.
• Occurrence of cardiac death during at 2, 3, 4 and 5 years follow-up
• Incidence of hospitalization due to angina pectoris or acute heart failure
• Incidence of implantation of implantable cardiac defibrillator (ICD) and/or pacemaker (PM).
• In patients where Cardiac-MRI is performed on a clinical routine basis: increase in global LV EF, measured by cardiac MRI
• In patients where myocardial scintigraphy is performed on a clinical routine basis: decrease in infarct size and stress-inducible myocardial ischemia measured by 99m-Tc-Sestamibi perfusion scintigraphy Methods: - Record of clinical events during the 5-year FUP
• Seattle angina questionnaire
• Electrocardiogram (ECG)
• Data evaluation of 99m-Technetium Sestamibi stress-rest myocardial scintigraphy if this examination was performed at 5 years clinical follow-up on a clinical routine basis
• Data evaluation of Cardiac-MRI if this examination was performed at 5 years clinical follow-up on a clinical routine basis