PMID- 17239678 OWN - NLM STAT- MEDLINE DCOM- 20070320 LR - 20071115 IS - 1097-6744 (Electronic) IS - 0002-8703 (Linking) VI - 153 IP - 2 DP - 2007 Feb TI - 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. PG - 212.e1-7 AB - 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. FAU - Nyolczas, Noemi AU - Nyolczas N AD - Department of Cardiology, Medical University of Vienna, Vienna, Austria. FAU - Gyongyosi, Mariann AU - Gyongyosi M FAU - Beran, Gilbert AU - Beran G FAU - Dettke, Markus AU - Dettke M FAU - Graf, Senta AU - Graf S FAU - Sochor, Heinz AU - Sochor H FAU - Christ, Gunther AU - Christ G FAU - Edes, Istvan AU - Edes I FAU - Balogh, Laszlo AU - Balogh L FAU - Krause, Korff T AU - Krause KT FAU - Jaquet, Kai AU - Jaquet K FAU - Kuck, Karl-Heinz AU - Kuck KH FAU - Benedek, Imre AU - Benedek I FAU - Hintea, Theodora AU - Hintea T FAU - Kiss, Robert AU - Kiss R FAU - Preda, Istvan AU - Preda I FAU - Kotevski, Vladimir AU - Kotevski V FAU - Pejkov, Hristo AU - Pejkov H FAU - Dudek, Darius AU - Dudek D FAU - Heba, Grzegorz AU - Heba G FAU - Sylven, Christer AU - Sylven C FAU - Charwat, Silvia AU - Charwat S FAU - Jacob, Ronaldo AU - Jacob R FAU - Maurer, Gerald AU - Maurer G FAU - Lang, Irene AU - Lang I FAU - Glogar, Dietmar AU - Glogar D LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Am Heart J JT - American heart journal JID - 0370465 SB - IM MH - Bone Marrow Transplantation/*methods MH - Coronary Vessels MH - Humans MH - Multicenter Studies as Topic MH - Myocardial Infarction/*surgery MH - Myocardium MH - Prospective Studies MH - Research Design MH - Single-Blind Method MH - Time Factors EDAT- 2007/01/24 09:00 MHDA- 2007/03/21 09:00 CRDT- 2007/01/24 09:00 PHST- 2006/05/24 00:00 [received] PHST- 2006/10/09 00:00 [accepted] PHST- 2007/01/24 09:00 [pubmed] PHST- 2007/03/21 09:00 [medline] PHST- 2007/01/24 09:00 [entrez] AID - S0002-8703(06)00948-3 [pii] AID - 10.1016/j.ahj.2006.10.027 [doi] PST - ppublish SO - Am Heart J. 2007 Feb;153(2):212.e1-7. doi: 10.1016/j.ahj.2006.10.027.