Duke Clinical Research Institute, Duke University, Durham, NC 27705, USA.
Am Heart J. 2011 Jul;162(1):47-55.e1. doi: 10.1016/j.ahj.2011.03.037.
Despite advances in care processes to improve reperfusion in patients with acute myocardial infarction (AMI), the short-term and 1-year mortality remains high, in part, because of reperfusion injury, microvascular obstruction, and infarct expansion. Intraaortic balloon counterpulsation (IABC) is an adjunct to revascularization and has reduced microvascular obstruction and infarct size in animal models of AMI.
CRISP AMI is a multicenter randomized trial that aims to determine if IABC initiated before percutaneous coronary intervention (PCI) for reperfusion compared with routine PCI in patients with anterior ST-segment elevation AMI reduces infarct size as measured by cardiac magnetic resonance imaging. Patients are randomly assigned to receive IABC initiated before primary PCI and continued for at least 12 hours or routine PCI with standard-of-care medical therapy in both groups. The primary efficacy end point is infarct size measured by cardiac magnetic resonance imaging at 3 to 5 days post-PCI. The secondary clinical end point is the composite of major adverse clinical events including death, reinfarction, and heart failure at 6 months. According to sample size calculation, 300 patients will be randomized at 50 sites across 10 countries.
The CRISP AMI study will determine if IABC before reperfusion in patients with anterior AMI reduces infarct size.
尽管在急性心肌梗死（AMI）患者的再灌注治疗方面已经取得了进展，但短期和 1 年死亡率仍然很高，部分原因是再灌注损伤、微血管阻塞和梗死面积扩大。主动脉内球囊反搏（IABC）是一种再灌注的辅助手段，已在 AMI 的动物模型中减少了微血管阻塞和梗死面积。
CRISP AMI 是一项多中心随机试验，旨在确定与常规 PCI 相比，在接受再灌注的经皮冠状动脉介入治疗（PCI）之前开始的 IABC 是否可以减少前壁 ST 段抬高型 AMI 患者的梗死面积，这是通过心脏磁共振成像测量的。患者被随机分配接受 IABC 治疗，在初次 PCI 前开始，并至少持续 12 小时，或在两组中接受常规 PCI 和标准医疗治疗。主要疗效终点是 PCI 后 3 至 5 天通过心脏磁共振成像测量的梗死面积。次要临床终点是包括死亡、再梗死和心力衰竭在内的主要不良临床事件的复合终点，在 6 个月时评估。根据样本量计算，将在 10 个国家的 50 个地点随机分配 300 名患者。
CRISP AMI 研究将确定在前壁 AMI 患者再灌注前进行 IABC 是否可以减少梗死面积。
