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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mariann Gyongyosi, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01395212
First received: July 14, 2011
Last updated: October 26, 2013
Last verified: October 2013
  Purpose

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).


Condition
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Changes in global EF [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Size of infarction [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Left ventricular end-diastolic and end-systolic volumes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Right ventricular end-diastolic and end-systolic volumes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Right ventricular cardiac output [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients included into the MYSTAR randomized study

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395212

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

No publications provided

Responsible Party: Mariann Gyongyosi, Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01395212     History of Changes
Other Study ID Numbers: MUW
Study First Received: July 14, 2011
Last Updated: October 26, 2013
Health Authority: Austria: Ethikkommission

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

Additional relevant MeSH terms:
Infarction
Heart Diseases
Myocardial Infarction
Coronary Artery Disease
Myocardial Ischemia
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 22, 2014