The University of Iowa Stroke Preclinical Assessment Network to Support Translational Studies for Acute Cerebroprotection

爱荷华大学中风临床前评估网络支持急性脑保护的转化研究

• 批准号: 10590946
• 负责人: Anil Kumar Chauhan
• 金额: $ 62.2万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-15 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10590946
• 关键词: Acute; Address; Adjuvant Therapy; Alteplase; American; Animals; Artificial Intelligence; Assessment tool; Blinded; Blood Vessels; Classification; Clinical; Clinical Trials; Clinical Trials Network; Coagulation Process; Collaborations; Comparative Study; Computing Methodologies; Consensus; Data; Development; Effectiveness; Enrollment; Environment; Enzymes; Epidemiology; Experimental Designs; Experimental Models; Filament; Frequencies; Future; Goals; Industry; Infrastructure; Institution; Intention; Intervention; Iowa; Ischemia; Ischemic Stroke; Logistics; Metabolic; Methodology; Mission; Modeling; Neurology; Outcome; Outcome Measure; Participant; Patients; Pattern; Performance; Positioning Attribute; Protocols documentation; Pyruvate Kinase; Randomized; Reperfusion Therapy; Reporting; Research; Research Infrastructure; Rodent; Rodent Model; Role; Site; Speed; Stroke; StrokeNet trials; Survival Rate; Technical Expertise; Testing; Thrombosis; Thrombus; Translational Research; United States National Institutes of Health; Universities; Uric Acid; Walking; adjudication; animal care; behavioral outcome; central database; cerebroprotection; cerebrovascular; comorbidity; cost; design; experience; functional improvement; improved; improved outcome; in vivo; innovation; neuroimaging; post stroke; pre-clinical; pre-clinical assessment; sex; stroke intervention; stroke model; stroke therapy; thromboinflammation; translational scientist; translational study; vibration

Project Summary The University of Iowa (UIowa) is poised to advance the field of cerebroprotection in patients with acute ischemic stroke by remaining as a site for the NIH Stroke Preclinical Assessment Network (SPAN)’s translational research infrastructure to efficiently conduct rigorous and innovative comparative studies of cerebroprotection in the context of reperfusion. UIowa-SPAN has consistently followed a rigorous, clinical trial-like approach to avoid the methodological mistakes of past cerebroprotection research. Specifically, we use randomization, blinded intervention, independent outcome adjudications, and intention-to-treat analyses to interpret and report our animal studies. We also address the effect of sex and comorbidities to increase the translational value of our research. UIowa-SPAN brings together a team of basic and translational scientists that integrates technical expertise with logistics. This has resulted in the top performance during the first iteration of SPAN, consistently leading the enrollment efficiency of the network while producing the highest quality data based on the metrics. We aim to maintain or exceed this performance if selected as a site in the new iteration of the network. Notably, the goals of UIowa-SPAN are aligned with those of UIowa’s regional coordinating center for StrokeNet, a NIH clinical trial network with the mission of identifying and testing promising stroke therapies. We are also proposing innovations to multiple aspects of the SPAN, including minimizing overall data variability, technical improvements in the embolic clot rodent model, and improvements to the internal validity of the current outcome measures, using artificial intelligence to interpret corner tests and alternative computation methods for the grid walk test. Our goal is to rigorously and efficiently identify which cerebroprotective interventions are likely to succeed in clinical trials in order to improve the outcomes of the 800,000 Americans who suffer a stroke and are currently treated with reperfusion strategies that have limited effectiveness.

项目摘要 爱荷华州大学（U爱荷华州）准备推进急性脑梗死患者的脑保护领域。 缺血性卒中，作为NIH卒中临床前评估网络（SPAN）的 翻译研究基础设施，以有效地进行严格和创新的比较研究， 再灌注背景下的脑保护。UIowa-SPAN一直遵循严格的，临床 尝试式的研究方法，避免了以往植物保护研究中的方法论错误。我们特别 使用随机化、盲法干预、独立结局裁定和意向治疗分析 解释和报告我们的动物研究。我们还讨论了性别和合并症的影响， 我们研究的转化价值UIowa-SPAN汇集了一支基础和翻译团队 科学家将技术专长与物流相结合。这导致了最高性能期间 SPAN的第一次迭代，始终领先于网络的注册效率，同时产生 基于度量的最高质量数据。我们的目标是保持或超过这一业绩，如果被选为 在网络的新迭代中的站点。值得注意的是，UIowa-SPAN的目标与UIowa的目标一致 StrokeNet的区域协调中心，这是一个NIH临床试验网络，其使命是识别和 测试有前景的中风疗法我们还对SPAN的多个方面提出了创新建议， 包括最大限度地减少总体数据变异性，栓塞凝块啮齿动物模型的技术改进，以及 改进当前结果测量的内部有效性，使用人工智能， 解释角测试和网格行走测试的替代计算方法。我们的目标是严格 并有效地确定哪些预防性干预措施可能在临床试验中取得成功， 改善80万美国中风患者的预后， 有效性有限的再灌注策略。