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.
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.
Nyolczas
Noémi
N
Department of Cardiology, Medical University of Vienna, Vienna, Austria.
Gyöngyösi
Mariann
M
Beran
Gilbert
G
Dettke
Markus
M
Graf
Senta
S
Sochor
Heinz
H
Christ
Günther
G
Edes
István
I
Balogh
László
L
Krause
Korff T
KT
Jaquet
Kai
K
Kuck
Karl-Heinz
KH
Benedek
Imre
I
Hintea
Theodora
T
Kiss
Róbert
R
Préda
István
I
Kotevski
Vladimir
V
Pejkov
Hristo
H
Dudek
Darius
D
Heba
Grzegorz
G
Sylven
Christer
C
Charwat
Silvia
S
Jacob
Ronaldo
R
Maurer
Gerald
G
Lang
Irene
I
Glogar
Dietmar
D
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