Nyolczas Noémi, Gyöngyösi Mariann, Beran Gilbert, Dettke Markus, Graf Senta, Sochor Heinz, Christ Günther, Edes István, Balogh László, Krause Korff T, Jaquet Kai, Kuck Karl-Heinz, Benedek Imre, Hintea Theodora, Kiss Róbert, Préda István, Kotevski Vladimir, Pejkov Hristo, Dudek Darius, Heba Grzegorz, Sylven Christer, Charwat Silvia, Jacob Ronaldo, Maurer Gerald, Lang Irene, Glogar Dietmar
Department of Cardiology, Medical University of Vienna, Vienna, Austria.
Am Heart J. 2007 Feb;153(2):212.e1-7. doi: 10.1016/j.ahj.2006.10.027.
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 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.
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.
既往数据表明，骨髓源性干细胞（BM-SCs）可减小梗死面积，并对梗死后重塑产生有益影响。
急性心肌梗死后心肌干细胞给药研究是一项多中心、前瞻性、随机、单盲临床试验，旨在比较急性心肌梗死（AMI）且梗死相关动脉已再通的患者早期及晚期冠状动脉内或联合（经皮心肌内和冠状动脉内）给予BM-SCs的情况。主要终点为BM-SCs治疗3个月后静息心肌灌注缺损大小和左心室射血分数（门控单光子发射计算机断层扫描[SPECT]闪烁显像）的变化。次要终点涉及评估：（1）应用方式的安全性和可行性；（2）左心室壁运动评分指数的变化（经胸超声心动图）；（3）心肌电压和节段性室壁运动（NOGA标测）；（4）左心室舒张末期和收缩末期容积（对比心室造影）；以及（5）随访时的临床症状（加拿大心血管学会[CCS]心绞痛评分和纽约心脏协会[NYHA]心功能分级）。360例患者被随机分为4组中的1组：A组，AMI后早期（21 - 42天）冠状动脉内注射治疗；B组，早期联合应用治疗；C组，AMI后晚期（3个月）冠状动脉内给药治疗；D组，晚期联合给予BM-SCs治疗。除BM-SCs治疗外，所有患者均采用AMI的标准化治疗。
急性心肌梗死后心肌干细胞给药试验是首个随机试验，旨在研究AMI后早期和晚期联合（心肌内和冠状动脉内）及冠状动脉内BM-SCs治疗方式的效果。
