Who Benefits from tPA 3-6 hours after Stroke

描述（由申请人提供）：目前，FDA批准的唯一治疗急性卒中的方法是在症状出现后3小时内静脉注射组织纤溶酶原激活剂（iv tPA）。在美国，只有3%的中风患者接受静脉注射tPA，因为大多数患者在接受静脉注射tPA的三小时时间限制后才去医院。尽管临床试验没有证明静脉注射tPA超过3小时的益处，但可能存在一个受益的中风患者亚组。为了增加接受tPA治疗的脑卒中患者的比例，需要确定这一亚组。候选人提出，在三个具体目标中，调查1)临床，2)计算机断层扫描（CT）和3)磁共振成像（MRI）特征是否有助于识别最有可能在3至6小时时间窗口内对iv tPA有良好反应的患者。基于这些项目的结果，候选人打算开发一种实用的临床预测工具，这将使医生能够对急性中风患者进行分层，并确定那些最有可能对tPA有良好反应的患者。Lansberg博士正在斯坦福大学医学中心完成他的脑血管研究，他将于2004年7月1日加入斯坦福大学神经病学和神经科学部门。他的职业目标是通过临床研究和直接患者护理来改善中风患者的健康状况。他的职业发展计划将高度相关的临床研究提案与补充教学培训相结合。他将完成临床流行病学和生物统计学的硕士学位，并将接受MRI技术的培训。导师团队由急性脑卒中临床研究、神经放射学、MRI物理、生物统计学等4个领域的世界知名学者组成。他们将在整个奖励期间提供指导，并促进他过渡到一个成功的独立调查员。

DESCRIPTION (provided by applicant): Currently, the only FDA approved treatment for acute stroke is intravenous tissue plasminogen activator (iv tPA) administered within three hours after symptom onset. Only three percent of stroke patients in the United States receive iv tPA, because most patients present to the hospital beyond the three hour time-limit for iv tPA. Although clinical trials have not demonstrated benefit from iv tPA beyond three hours, a subgroup of stroke patients who benefit is likely to exist. This subgroup needs to be identified in order to increase the proportion of stroke patients who may be treated with tPA. The candidate proposes, in three Specific Aims, to investigate whether 1) clinical, 2) computed tomography (CT) and 3) magnetic resonance imaging (MRI) characteristics help identify patients who are most likely to have a favorable response to iv tPA in the three to six hour time-window. Based on the results of these projects, the candidate intents to develop a practical clinical prediction tool, which will enable physicians to stratify acute stroke patients and identify those who are most likely to have a favorable response to tPA. Dr. Lansberg is completing his Cerebrovascular Fellowship at Stanford University Medical Center and he will join the staff of the Department of Neurology and Neurological Sciences at Stanford University on July 1, 2004. His career goal is to improve the health of stroke patients through clinical research and direct patient care. His career development plan combines a highly relevant clinical research proposal with complementary didactic training. He will complete a Master of Science Program in Clinical Epidemiology and Biostatistics and he will get training in MRI technology. The candidate has a team of mentors who are world-renowned researchers in the following four fields: Clinical studies of acute stroke, neuroradiology, MRI physics and biostatistics. They will provide guidance throughout the award period and facilitate his transition into a successful independent investigator.