title: Design and rationale for the Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: a multicenter, prospective, randomized, single-blind trial comparing early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of nonselected autologous bone marrow cells to patients after acute myocardial infarction.
abstract: BACKGROUND
  Previous data suggest that bone marrow-derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling.
  
  
  METHODS
  The Myocardial Stem Cell Administration After Acute Myocardial Infarction 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 end points are the changes in resting myocardial perfusion defect size and left ventricular ejection fraction (gated single photon emission computed tomography [SPECT] scintigraphy) 3 months after BM-SCs therapy. The secondary end points 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 (Canadian Cardiovascular Society [CCS] anina score and New York Heart Association [NYHA] functional class) at follow-up. Three hundred sixty patients are randomly assigned into 1 of 4 groups: group A, early treatment (21-42 days after AMI) with intracoronary injection; group B, early treatment with combined application; group C, late treatment (3 months after AMI) with intracoronary delivery; and group D, late treatment with combined administration of BM-SCs. Besides the BM-SCs therapy, the standardized treatment of AMI is applied in all patients.
  
  
  CONCLUSIONS
  The Myocardial Stem Cell Administration After Acute Myocardial Infarction 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.
authors.affiliation: Department of Cardiology, Medical University of Vienna, Vienna, Austria.
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authors.forename: László
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authors.lastname: Krause
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authors.forename: Karl-Heinz
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authors.lastname: Kuck
authors.forename: Imre
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authors.lastname: Benedek
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authors.forename: Róbert
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authors.forename: Hristo
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authors.lastname: Pejkov
authors.forename: Darius
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authors.lastname: Dudek
authors.forename: Grzegorz
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authors.forename: Christer
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authors.forename: Silvia
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authors.lastname: Charwat
authors.forename: Ronaldo
authors.initials: R
authors.lastname: Jacob
authors.forename: Gerald
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authors.lastname: Maurer
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authors.forename: Dietmar
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authors.lastname: Glogar
mesh_terms: D016026:Bone Marrow Transplantation / Q000379:methods*; D003331:Coronary Vessels; D006801:Humans; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000601:surgery*; D009206:Myocardium; D011446:Prospective Studies; D012107:Research Design; D016037:Single-Blind Method; D013997:Time Factors