Duke Testing Site for Stroke Preclinical Assessment Network

杜克中风临床前评估网络测试站点

• 批准号: 10591716
• 负责人: HUAXIN SHENG
• 金额: $ 49.91万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-15 至 2025-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10591716
• 关键词: Acute; Adjuvant; Affect; Age; Animal Behavior; Animal Model; Animals; Behavior; Biological; Blinded; Brain; Brain Injuries; Cephalic; Clinical; Clinical Trials; Collaborations; Custom; Data Analyses; Data Reporting; Dedications; Disease model; Eligibility Determination; Ensure; Equipment; Experimental Designs; Filament; Freezing; Goals; Guidelines; Health; Human Resources; Hypertension; Image; Infarction; Infrastructure; Institution; Intervention; Ischemia; Ischemic Stroke; Knowledge; Laboratories; Long-Term Effects; Magnetic Resonance Imaging; Mechanics; Medical; Metabolic; Middle Cerebral Artery Occlusion; Mission; Modeling; Monitor; Mus; National Institute of Neurological Disorders and Stroke; Nervous System Physiology; Neurologist; Operative Surgical Procedures; Outcome Assessment; Outcome Measure; Physiology; Preclinical Testing; Procedures; Protocols documentation; Public Health; Qualifying; Quality of life; Randomized; Rattus; Reperfusion Injury; Reperfusion Therapy; Research; Research Infrastructure; Research Personnel; Resources; Rodent Model; Scientist; Site; Statistical Methods; Stroke; Testing; Therapeutic; Therapeutic Intervention; Thrombectomy; Tissues; Training; Treatment Efficacy; United States; United States National Institutes of Health; Universities; Work; Writing; behavior test; brain tissue; cerebroprotection; clinically relevant; combat; comorbidity; data sharing; design; drug testing; effective intervention; efficacy evaluation; efficacy testing; experience; experimental study; improved; intervention effect; meetings; nervous system disorder; pre-clinical; pre-clinical assessment; preclinical evaluation; preclinical imaging; provider intervention; public health relevance; recruit; response; sex; skills; stroke model; stroke outcome; stroke patient; stroke survivor; stroke therapy; stroke trials; success

Abstract Stroke is a severe medical condition that affects about 800,000 in the United States every year, and 87% of these strokes are ischemic. Recent advances in mechanical thrombectomy have substantially increased the number of acute ischemic stroke patients who are eligible for reperfusion therapy. To further improve stroke outcome, there is an urgent need to identify effective cerebroprotective interventions as adjunct treatments to reperfusion therapy after ischemic stroke. Indeed, the NINDS Stroke Preclinical Assessment Network (SPAN) has called for highly promising cerebroprotective interventions to be simultaneously tested in multi-site preclinical settings before advancing to clinical trials. The goal of this application is to participate in SPAN as a testing laboratory to assess the efficacy of interventions selected by SPAN to improve long-term stroke outcome. As a preclinical testing site, we will perform our assessments in transient ischemic stroke animals in a controlled, randomized, and blinded fashion, following the standard protocols developed with NINDS and the SPAN Coordinating Center (CC). We have assembled a strong Duke University investigative team from 4 departments that includes basic and clinical stroke scientists, neurologists, neuroradiologists, behavior scientists, and biostatisticians, and that has had an excellent preclinical stroke research record for over 2 decades. The team has well established stroke models that meet the needs of long-term preclinical testing with consideration for relevant biological variables such as sex and age, as well as ischemic stroke-related comorbidities. Multiple quantitative behavioral tests and advanced MRI imaging are in place to support clinically relevant outcome assessments. Collectively, this team has the experience, knowledge, skills, and equipment required to join SPAN as a well-qualified testing site. The Duke site also has a scientific, administrative, and institutional commitment to collaborate with the CC, other sites, and intervention providers for in-parallel testing of up to 8 cerebroprotective interventions and timely data sharing and reporting. We expect to find that the most promising interventions, identified by SPAN, can be advanced into clinical trials, and bring hope to stroke patients.

摘要 中风是一种严重的医学疾病，每年在美国影响约80万人，87%的人患有中风。 这些中风是缺血性的机械血栓切除术的最新进展大大增加了 有资格接受再灌注治疗的急性缺血性卒中患者数量。为了进一步改善中风 因此，迫切需要确定有效的预防性干预措施作为辅助治疗， 缺血性卒中后的再灌注治疗。NINDS中风临床前评估网络（SPAN） 呼吁在多个临床前研究中心同时测试非常有前途的神经保护干预措施， 在进入临床试验之前进行设置。此应用程序的目标是作为测试参与SPAN 实验室评估SPAN选择的干预措施改善长期卒中结局的疗效。作为 临床前试验中心，我们将在对照的短暂性缺血性卒中动物中进行评估， 按照NINDS和SPAN开发的标准方案， 协调中心。我们从4个系组成了一个强大的杜克大学调查小组 包括基础和临床中风科学家，神经学家，神经放射学家，行为科学家， 生物统计学家，并已超过20年的临床前中风研究记录。球队 已建立完善的卒中模型，满足长期临床前试验的需求，并考虑 相关的生物学变量，如性别和年龄，以及缺血性卒中相关的合并症。多 定量行为测试和先进的MRI成像可支持临床相关结果 评估。总的来说，这个团队拥有加入SPAN所需的经验、知识、技能和设备 作为一个合格的测试场所。该杜克网站也有一个科学，行政和制度的承诺 与CC、其他研究中心和干预提供者合作，进行多达8个 脑保护干预措施以及及时的数据共享和报告。我们希望找到最有希望的 SPAN确定的干预措施可以进入临床试验，并为中风患者带来希望。