PREDICTION OF HUMAN BRAIN INFARCTION BY MRI

我们建议进行一项先导性、双盲、安慰剂对照、随机临床试验，用一种有前途的新型抗血栓药物血小板糖蛋白（GP）IIb/IIIa受体抑制剂阿昔单抗治疗急性缺血性卒中，并采用临床和新型MRI结局指标相结合，最终目标是将MRI技术整合到治疗急性缺血性卒中的II/III期临床试验中。我们希望本研究的数据将有助于确定在缺血性卒中急性期使用阿昔单抗治疗是否能改善早期和慢性神经功能结局。该试验还将寻求定义该治疗剂活性的MRI替代标志物，并将临床结果评估参数与治疗前和治疗后MRI测量相关联。将寻求MRI标记物来区分那些可能对治疗剂有反应的患者与那些由于晚期脑组织损伤而不太可能对治疗剂有反应的患者。我们相信，本研究的结果将导致急性缺血性卒中后续II期或III期治疗性临床试验的设计和效率的实质性改进。

We propose to conduct a pilot, double-blind, placebo-controlled, randomized clinical trial to treat acute ischemic stroke with a promising new anti-thrombotic agent, the platelet glycoprotein (GP) IIb/IIIa receptor inhibitor abciximab, and to employ a combination of clinical and novel MRI outcome measures, with the ultimate goal of integrating MRI technology into Phase II/III clinical trials of treatment of acute ischemia stroke. We expect that the data derived from this study will help determine whether treatment with abciximab in the acute phase of ischemic stroke results in improved early and chronic neurological outcome. This trial will also seek to define MRI surrogate markers of activity of t his therapeutic agent and to correlate clinical outcome assessment parameters with pre- and post-treatment MRI measures. MRI markers will be sought to discriminate those patients who are likely to respond to therapeutic agent from those who are unlikely to respond to the therapeutic agent because of advanced brain tissue injury. We believe that the results from the present study will lead to substantial improvements in the design and efficient of subsequent Phase II or III therapeutic clinical trials of acute ischemic stroke.