MYSTAR-5-YEAR: Long-term Follow-up of Patients With Ischemic Heart Disease Treated With Cell Therapy

Study Overview
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Brief Summary
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The MYSTAR-5-YEAR study controls the patients 5 years after treatment with combined (intramyocardial and intracoronary) delivery of autologous BM-MNCs. The clinical endpoint of this prospective non-randomized observational study is the MACCE, defined as major adverse cardiac and cerebrovascular events. Patients will be investigated by echocardiography, SPECT and MRI. 2D (NOGA-guided SPECT) and 3D (NOGA-guided MRI) imaging will refine the evaluation with more exact analysis of the intramyocardial injected areas (ROI).

Detailed Description
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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 (major adverse cardiac and cerebrovascular events, including all-cause death, re-AMI, revascularization and stroke) during the mean 5 years follow-up. Secondary endpoints: improvements of clinical symptoms, expressed as CCS and NYHA scores, change in global LV EF, measured by echocardiography, size of infarction determined by stress-rest SPECT, LV and RV volumes, function and cardiac output measured by cardiac MRI.

Official Title
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Long-term Follow-up of Patients With Ischemic Heart Disease Treated With Combined Delivery of Autologous Bone-marrow Mononuclear Cells: 5-year Clinical Outcome of the MYSTAR Study

Conditions
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Acute Myocardial Infarction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous participation in the MYSTAR study, inclusion either in the Early or Late groups Signed informed consent Exclusion Criteria: Non-willingness of participation in the present FUP study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac stem cell therapy 5 years ago<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of MACCE | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptoms (CCS, NYHA) |  | 5 years | 
| Changes in global EF |  | 5 years | 
| Size of infarction |  | 5 years | 
| Left ventricular end-diastolic and end-systolic volumes |  | 5 years | 
| Right ventricular end-diastolic and end-systolic volumes |  | 5 years | 
| Right ventricular cardiac output |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cell-based cardiac regenerative therapy, Intramyocardial injections, NOGA procedure, Acute myocardial infarction