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

July 14, 2011
October 26, 2013
July 2011
May 2013   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01395212 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
MYSTAR-5-YEAR: Long-term Follow-up of Patients With Ischemic Heart Disease Treated With Cell Therapy
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

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).

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients included into the MYSTAR randomized study

Acute Myocardial Infarction
Not Provided
Cardiac stem cell therapy 5 years ago
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01395212
MUW
No
Mariann Gyongyosi, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Mariann Gyöngyösi, MD PhD Medical University of Vienna
Medical University of Vienna
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP