Stroke Trials Network of Columbia and Cornell

哥伦比亚大学和康奈尔大学中风试验网络

• 批准号: 10767024
• 负责人: EDWARD SANDER CONNOLLY
• 金额: $ 18.64万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10767024
• 关键词: Academic Medical Centers; Acute; Admission activity; Adult; African American; Ancillary Study; Asian; Carotid Stenosis; Clinical Trials; Cognition; County; Data; Development; Disease; Enrollment; Failure; Fellowship; Funding; Goals; Heart Atrium; Hispanic; Hospitals; Infrastructure; Institution; K-Series Research Career Programs; Leadership; Manuscripts; Minority Groups; National Institute of Neurological Disorders and Stroke; New Jersey; New York; Patients; Phase; Population; Positioning Attribute; Productivity; Randomized, Controlled Trials; Recovery; Rehabilitation Centers; Role; Side; Site; Standardization; Stroke; Testing; Training and Education; United States National Institutes of Health; Vascularization; cerebral hemodynamics; clinical trial enrollment; cryptogenic stroke; demographics; disability; improved; innovation; meetings; member; mortality; neurosurgery; patient subsets; professor; programs; screening; stroke clinical trials; stroke therapy; stroke trials; success; symposium; trial enrollment; underserved minority; videoconference; working group

NINDS Stroke Trials Network Regional Coordinating Center (RCC) application RS Marshall, ES Connolly, D Leifer, M Fink, P Stieg, Co-PIs SUMMARY The Stroke Trials Network of Columbia and Cornell (STNCC) has a primary goal of maximizing stroke clinical trial enrollment for New York. Columbia and Cornell, situated on the west and east side of Manhattan, respectively, will form the two hubs, supported by an Acute Treatment Sub-network of 3 hospitals in Brooklyn and New Jersey, a Recovery Sub-network comprising 2 affiliated academic Rehabilitation Centers in Westchester County and New Jersey, and 4 Academic Medical Centers in Brooklyn and in Western New York. Our hubs and satellites treated just over 8,700 strokes in 2022. More importantly, our RCC has an extensive leadership record in stroke clinical trials, and have the distinction of being the leading enroller in Stroke clinical trials over the first 5 years of StrokeNet; Our total enrollment as of November 2022 was 775 subjects, including the trials rolling into StrokeNet from prior years. The demographics in our network overall are very favorable for enrolling underserved minority populations: Columbia has 40% Hispanic and 25% African American; Cornell 15% Asian, and St. Joseph’s 24% African American, 30% Hispanic, 12% other. Part of our success is due to the highly organized and interactive infrastructure. We hold monthly videoconferences attended by PIs and coordinators from all RCC hubs and satellite sites, and standardized daily stroke admission screening across the RCC. These data as well as trial enrollments are reviewed at the monthly videoconference calls. In addition to our contributions in clinical trial enrollment, the STNCC has been extremely active in leadership roles in the first 10 years. Dr. Randolph Marshall and Dr. Dana Leifer have been regular members of the StrokeNet Steering Committee for 10 years. Dr. Marshall served on the NCC Executive Committee for years 1 and 2. He is also Chair of the Education and Training Core, having served as Co-Chair for 7 years prior. Dr. Ron Lazar (now at UAB), served on the Recovery Working Group in years 1 and 2, and was succeeded by Dr. Marshall, later joined by Co-I Dr. Tomoko Kitago in 2021. Dr. Connolly served on the neurosurgical advisory group. We have had 100% participation at all national meetings and conference calls. In terms of innovation and clinical trial development, our RCC has the distinction of submitting and obtaining funding for two of the StrokeNet RCTs. STNCC Co-Is Mitchell Elkind and Hooman Kamel are Co-PI’s on the ARCADIA trial, a multi-center Phase 3 RCT to determine whether apixaban is superior to standard therapy for patients with cryptogenic stroke and “atrial cardiopathy.” Randolph Marshall, Sander Connolly, and Ronald Lazar are Co-PI’s on the CREST-H study, an ancillary study to the CREST-2 trial, testing the hypothesis that revascularization can improve cognition in as subset of patients with high grade asymptomatic carotid stenosis who have cerebral hemodynamic failure. Finally, our StrokeNet trainee program has been highly successful, with 11 trainees producing 22 abstracts and 58 manuscripts within 1 year of Fellowship, and 10 have Assistant Professor positions at major academic institutions (all StrokeNet sites). Two have had for K-awards and 2 have R01s.

NINDS卒中试验网络区域协调中心（RCC）申请 RS马歇尔、ES Connolly、D Leifer、M Fink、P Stieg、Co-PI 总结 哥伦比亚和康奈尔大学的中风试验网络（STNCC）的主要目标是最大限度地提高中风的临床治疗效果。 纽约的试验招募。位于曼哈顿东西两侧的哥伦比亚和康奈尔， 将形成两个中心，由布鲁克林3家医院组成的急性治疗子网络提供支持 和新泽西，一个恢复子网络，包括2个附属的学术康复中心， 韦斯特切斯特县和新泽西，以及布鲁克林和纽约西部的4个学术医疗中心。 我们的中心和卫星在2022年治疗了超过8，700次中风。更重要的是，我们的RCC拥有广泛的 在中风临床试验中的领导记录，并在中风临床试验中成为领先的招募者 截至2022年11月，我们的总入组人数为775名受试者，包括 前几年进入中风网的试验我们网络中的人口统计数据总体上非常有利于 招收服务不足的少数民族人口：哥伦比亚有40%的西班牙裔和25%的非洲裔美国人;康奈尔大学 15%亚洲人，圣约瑟夫24%非裔美国人，30%西班牙裔，12%其他。我们的成功部分归功于 高度组织化和互动的基础设施。我们每月举行由私人侦探参加的视频会议， 所有RCC中心和卫星中心的协调员，以及标准化的每日中风入院筛查， RCC。在每月的视频电话会议上审查这些数据以及试验入组情况。此外 由于我们在临床试验招募方面的贡献，STNCC在以下方面一直非常积极地发挥领导作用： 头十年。兰多夫马歇尔博士和达纳莱费尔博士一直是中风网络指导的正式成员 委员会10年。马歇尔博士在NCC执行委员会任职1年和2年。他也是 教育和培训核心小组主席，此前曾担任7年联合主席。罗恩拉扎尔博士（现为 UAB），第1年和第2年在恢复工作组任职，由马歇尔博士继任，后来加入 由Co-I Tomoko Kitago博士于2021年。康诺利医生在神经外科顾问小组工作。我们有 100%参加所有国家会议和电话会议。在创新和临床试验方面 在开发过程中，我们的RCC在为两项StrokeNet RCT提交和获得资金方面表现出色。 STNCC Co-Is Mitchell Elkind和Hooman Kamel是ARCADIA试验（一项多中心III期RCT）的共同主要研究者 为了确定阿哌沙班是否上级于标准治疗隐源性卒中和“心房颤动”患者， 心脏病”兰多夫马歇尔、桑德康诺利和罗纳德拉扎尔是CREST-H研究的共同PI， CREST-2试验的辅助研究，检验血运重建可以改善认知的假设， 脑血流动力学衰竭的高度无症状颈动脉狭窄患者亚组。 最后，我们的StrokeNet培训生项目非常成功，11名培训生撰写了22篇摘要 和58个手稿在1年的奖学金，和10个助理教授职位，在主要学术 机构（所有StrokeNet网站）。两个有K奖，两个有R 01。