Mallinckrodt公司含钆造影剂OptiMark

一种使用新型造影剂的II期临床试验已经成功完成，在试验中检测了使用OptiMark(钆弗塞胺)造影剂在检测心肌梗塞表现、位置与程度方面的安全性与有效性。

这项首次大规模多中心国际临床试验结果在美国奥兰多(FL, USA)举行的美国心脏病学院（ACC）年会上进行了报道。从这些剂量范围探索试验中获取的信息确证了在疑似心脏病发作患者中的最佳剂量，而且显示了在这个患者人群中药物的安全性。

这项II期临床试验包括了23个国际医疗中心的600多位患者与26名研究人员。OptiMark是由Mallinckrodt公司研制开发的，这是Tyco健康保健(Mansfield, MA, USA)的商业机构。其它用于检测有活力心肌的不同造影方法包括铊核素造影、氟-18去氧葡萄糖(FDG)正电子发射断层摄影(PET)以及超声心动图。尽管已经在临床实践中使用，这项技术有着一些局限性包括造影窗口较差、缺乏足够的清晰度、人工衰减导致模糊影像以及缺乏待机途径。

核磁共振能够鉴别出有活力心脏组织与已经发生疤痕改变的组织或者心脏病发作导致死亡的组织之间的区别。使用钆为基质的对比造影剂例如OptiMark能够增强疤痕组织或者无活力组织区域。
 
Imaging Agent to Detect Heart Attacks
 
A new imaging agent has successfully completed two phase II studies using the OptiMark (gadoversetamide) imaging agent to determine the safety and effectiveness in detecting the presence, location, and extent of myocardial infarctions.

The findings of these first large, multicenter international trials were presented in March 2005 at the annual meeting of the American College of Cardiology (ACC) in Orlando (FL, USA). The information retrieved from these dose-ranging studies demonstrated the optimal dose to use in patients with a suspected heart attack and also showed the safety of the agent in this patient population.

The phase II trials included more than 600 patients and 26 researchers at 23 international medical centers. OptiMark was developed by Mallinckrodt, a business unit of Tyco Healthcare (Mansfield, MA, USA). Other imaging methods used to detect viable myocardium include thallium nuclear imaging, fluorodeoxyglucose (FDG) positron emission tomography (PET), and echocardiography. Although used clinically, these techniques have several limitations including poor imaging windows, lack of adequate resolution, attenuation artifacts causing blurred images, and lack of ready access.

MRI is able to identify the difference between living heart tissue and tissue that has become scarred or has died as a result of a heart attack. The use of gadolinium-based contrast agents such as OptiMark has been found to enhance areas of scarred or nonviable tissue.