Duke Testing Site for Stroke Preclinical Assessment Network

杜克中风临床前评估网络测试站点

基本信息

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
项目类别：
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

项目摘要

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.

抽象的中风是一种严重的医疗状况，每年影响约80万，其中87％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疗法的急性缺血性中风患者的数量。进一步改善中风结果，迫切需要确定有效的脑保护干预措施作为辅助治疗缺血性中风后再灌注疗法。实际上，Ninds中风临床前评估网络（SPAN）曾要求在多站点临床前同时测试高度有希望的脑保护干预措施在进行临床试验之前的设置。该应用程序的目的是作为测试参与跨度实验室评估SPAN选择的干预措施以改善长期中风结果的功效。作为临床前测试地点，我们将在受控的，按照Nind和跨度制定的标准协议，随机和盲人的时尚协调中心（CC）。我们已经组建了来自四个部门的强大杜克大学调查小组其中包括基本和临床中风科学家，神经科医生，神经放射学家，行为科学家以及生物统计学家，它拥有超过20年的出色临床前中风研究记录。团队已经建立了良好的中风模型，可满足长期临床前测试的需求相关的生物学变量，例如性别和年龄以及缺血性中风相关的合并症。多种的定量行为测试和高级MRI成像已适当支持临床相关结果评估。总的来说，该团队拥有加入SPAN所需的经验，知识，技能和设备作为合格的测试地点。杜克大学还具有科学，行政和机构的承诺与CC，其他站点和干预提供商合作，以最多为8 脑保护干预措施以及及时的数据共享和报告。我们希望发现最有前途的通过SPAN确定的干预措施可以进行临床试验，并为中风患者带来希望。