Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study (MYSTAR)
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|ClinicalTrials.gov Identifier: NCT00384982|
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : January 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Procedure: Bone marrow-derived stem cells implantation||Phase 2|
Previous data suggest that bone marrow-derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling.
The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of BM-SCs to patients after acute myocardial infarction (AMI) with reopened infarct-related artery.
The primary endpoints are the changes in resting myocardial perfusion defect size and left ventricular ejection fraction (gated SPECT scintigraphy) 3 months after BM-SCs therapy.
The secondary endpoints relate to evaluation of 1) the safety and feasibility of the application modes, 2) the changes in left ventricular wall motion score index (transthoracic echocardiography), 3) myocardial voltage and segmental wall motion (NOGA mapping), 4) left ventricular end-diastolic and end-systolic volumes (contrast ventriculography), and 5) the clinical symptoms (CCS and NYHA) at follow-up.
Patients are randomly assigned into one of four groups, Group A: early treatment (21-42 days after AMI) with intracoronary injection; Group B: early treatment (21-42 days after AMI) with combined (intramyocardial and intracoronary) application; Group C: late treatment (3 months after AMI) with intracoronary delivery; and Group D: late treatment (3 months after AMI) with combined (intramyocardial and intracoronary) administration of BM-SCs. Besides the BM-SCs therapy, the standardized treatment of AMI is applied in all patients.
The MYSTAR trial is the first randomized trial to investigate the effects of the combined (intramyocardial and intracoronary) and the intracoronary mode of delivery of BM-SCs therapy in the early and late periods after AMI.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: A Multicenter, Randomized Trial Comparing Early and Late Intracoronary or Combined (Intramyocardial and Intracoronary) Administration of Stem Cells|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Experimental: A, B, C, D
Early or late; percutaneous intracoronary or combined (intramyocardial and intracoronary) administration of BM-MNCs
Procedure: Bone marrow-derived stem cells implantation
percutaneous BM-derived cell therapy
- Changes in resting myocardial perfusion defect size by gated SPECT scintigraphy 3-6 months after the percutaneous intracoronary or combined bone marrow-derived stem cells therapy. [ Time Frame: 3-6 month ]
- Changes in global left ventricular ejection fraction by gated SPECT scintigraphy 3-6 months after the percutaneous intracoronary or combined bone marrow-derived stem cells therapy. [ Time Frame: 3-6 month ]
- The feasibility of the bone marrow-derived stem cells delivery modes, determined by the rates of acute and subacute complications [ Time Frame: in-hospital ]
- Change in the left ventricular wall motion score index, measured by transthoracic echocardiography [ Time Frame: 3-6 month ]
- Change in the myocardial voltage as a parameter of myocardial viability obtained by NOGA endocardial mapping, with segmental wall motion expressed by local linear shortening on NOGA mapping [ Time Frame: 3-6 month ]
- Change in left ventricular end-diastolic and end-systolic volumes by contrast ventriculography [ Time Frame: 3-6 month ]
- Assessment of the clinical symptoms (CCS and NYHA) of the patients [ Time Frame: 3, 6 and 12 month ]
- The safety of the bone marrow-derived stem cells delivery modes, expressed as the rates of long-term major adverse cardiac events (MACE: death, target vessel revascularization and non-fatal AMI) [ Time Frame: 3, 6 and 12 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384982
|Department of Cardiology, Medical University of Vienna|
|Vienna, Austria, 1090|
|Study Director:||Irene Lang, MD||Department of Cardiology, Medical University of Vienna|
|Study Chair:||Dietmar Glogar, MD||Department of Cardiology, Medical University of Vienna|
|Principal Investigator:||Mariann Gyongyosi, MD||Department of Cardiology, Medical University of Vienna|