Who Benefits from tPA 3-6 hours after Stroke

中风后 3-6 小时谁可以从 tPA 中受益

• 批准号: 7615482
• 负责人: MAARTEN G LANSBERG
• 金额: $ 17.38万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-01 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7615482
• 关键词: Academic Medical Centers; Acute; Alteplase; Award; Biometry; Characteristics; Clinical; Clinical Research; Clinical Trials; Data; Development Plans; Disease; Educational Curriculum; Enrollment; Epidemiology; FDA approved; Fellowship; Future; Goals; Health; Hospitals; Hour; Imaging technology; Individual; Intravenous; Magnetic Resonance Imaging; Master of Science; Mentors; Modeling; National Institute of Neurological Disorders and Stroke; Neurologic; Neurology; Patient Selection; Patients; Physicians; Physics; Research; Research Personnel; Research Proposals; Science; Stroke; Structure; Subgroup; Symptoms; Time; Training; United States; Universities; Work; X-Ray Computed Tomography; acute stroke; base; career; career development; cerebrovascular; clinical epidemiology; direct patient care; improved; neuroimaging; placebo controlled study; programs; response; skills; thrombolysis; tool; trend

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.

描述（由申请人提供）：目前，FDA 批准的唯一治疗急性中风的方法是在症状出现后三小时内注射静脉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，因为大多数患者到医院就诊的时间超过了静脉注射 tPA 的三小时时限。尽管临床试验尚未证明超过三小时的静脉注射 tPA 能带来益处，但可能存在受益的中风患者亚组。需要确定这一亚组，以增加可以接受 tPA 治疗的中风患者比例。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对 iv tPA 产生良好反应的患者三到六个小时的时间窗口。根据这些项目的结果，候选人打算开发一种实用的临床预测工具，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 产生良好反应的患者。 Lansberg 博士即将完成斯坦福大学医学中心的脑血管奖学金，并将于 2004 年 7 月 1 日加入斯坦福大学神经病学和神经科学系。他的职业目标是通过临床研究改善中风患者的健康和直接的病人护理。他的职业发展计划将高度相关的临床研究提案与补充性的教学培训结合起来。他将完成临床流行病学和生物统计学理学硕士课程，并将接受 MRI 技术的培训。候选人拥有一支由以下四个领域的世界知名研究人员组成的导师团队：急性中风的临床研究、神经放射学、MRI物理学和生物统计学。他们将在整个奖励期间提供指导，并帮助他转变为一名成功的独立调查员。