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

This study has been completed.
Information provided by (Responsible Party):
Mariann Gyongyosi, Medical University of Vienna Identifier:
First received: July 14, 2011
Last updated: October 26, 2013
Last verified: October 2013

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).

Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Occurrence of MACCE [ Time Frame: 5 years ]
    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.

Secondary Outcome Measures:
  • Clinical symptoms (CCS, NYHA) [ Time Frame: 5 years ]
  • Changes in global EF [ Time Frame: 5 years ]
  • Size of infarction [ Time Frame: 5 years ]
  • Left ventricular end-diastolic and end-systolic volumes [ Time Frame: 5 years ]
  • Right ventricular end-diastolic and end-systolic volumes [ Time Frame: 5 years ]
  • Right ventricular cardiac output [ Time Frame: 5 years ]

Enrollment: 60
Study Start Date: July 2011
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Cardiac stem cell therapy 5 years ago

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients included into the MYSTAR randomized study

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
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Please refer to this study by its identifier: NCT01395212

Medical University of Vienna
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Mariann Gyöngyösi, MD PhD Medical University of Vienna
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mariann Gyongyosi, Prof. Dr., Medical University of Vienna Identifier: NCT01395212     History of Changes
Other Study ID Numbers: MUW
Study First Received: July 14, 2011
Last Updated: October 26, 2013

Keywords provided by Medical University of Vienna:
Cell-based cardiac regenerative therapy
Intramyocardial injections
NOGA procedure
Acute myocardial infarction

Additional relevant MeSH terms:
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases processed this record on May 25, 2017