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 - 09/08/11

Doi : 10.1016/j.ahj.2006.10.027

Noémi Nyolczas, MD, FESC ^a,^b, Mariann Gyöngyösi, MD ^a,^⁎, Gilbert Beran, MD ^a, Markus Dettke, MD ^c, Senta Graf, MD ^a, Heinz Sochor, MD, FESC ^a, Günther Christ, MD ^a, István Édes, MD, PhD, FESC ^d, László Balogh, MD ^d, Korff T. Krause, MD ^e, Kai Jaquet, MD ^e, Karl-Heinz Kuck, MD ^e, Imre Benedek, MD ^f, Theodora Hintea, MD ^f, Róbert Kiss, MD, PhD ^b, István Préda, MD, PhD, FESC ^b, Vladimir Kotevski, MD, FESC ^g, Hristo Pejkov, MD ^g, Darius Dudek, MD ^h, Grzegorz Heba, MD ^h, Christer Sylven, MD ⁱ, Silvia Charwat, MD ^a, Ronaldo Jacob, MD ^a, Gerald Maurer, MD, FACC ^a, Irene Lang, MD ^a, Dietmar Glogar, MD, FESC ^a
^a Department of Cardiology, Medical University of Vienna, Vienna, Austria
^b Department of Cardiology and Internal Medicine, National Health Service Center, Budapest, Hungary
^c Department of Transfusion Medicine, Medical University of Vienna, Vienna, Austria
^d Department of Cardiology, University of Debrecen, Debrecen, Hungary
^e Cardiology, AK St. Georg, Hamburg, Germany
^f Department of Cardiology, University of Targu Mures, Targu Mures, Romania
^g Uni-Clinic-Center, University “St. Cyril and Methodius,” Skopje, Macedonia
^h Institute of Cardiology, Krakow, Poland
ⁱ Karolinska University Hospital at Huddinge, Karolinska Institute, Stockholm, Sweden

^⁎Reprint requests: Mariann Gyöngyösi, Department of Cardiology, Medical University of Vienna, Währinger Gürtel 18-20, A-1090 Vienna, Austria.

Riassunto

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.

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Statistical analysis and sample size calculation

Summary

The study is supported by an educational grant from the OMAA (Austrian-Hungarian Action Foundation-60—u7-) and the Austrian Society of Cardiology to Dr Nyolczas.

Esportazione

Vol 153 - N° 2

P. 212.e1-212.e7 - Febbraio 2007 Ritorno al numero

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