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: 10306036
• 负责人: EDWARD SANDER CONNOLLY
• 金额: $ 31.68万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10306036
• 关键词: Academic Medical Centers; Acute; Admission activity; Adult; African American; Ancillary Study; Area; Asians; Biological Markers; Carotid Stenosis; Childhood stroke; Clinical; Clinical Research; Clinical Trials; Cognition; County; Data; Development; Disease; Enrollment; Failure; Fellowship; Funding; Goals; Heart Atrium; Hispanics; Hospitals; Human; Infrastructure; Institution; K-Series Research Career Programs; Leadership; Manuscripts; Mentors; Minority Groups; Neurologist; Neurosciences; New Jersey; New York; Outcome Study; Patients; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Population; Populations at Risk; Positioning Attribute; Productivity; Randomized Controlled Trials; Recovery; Rehabilitation Centers; Rehabilitation therapy; Resources; Role; Science; Side; Site; Standardization; Stroke; Stroke prevention; Testing; Training; Training and Education; United States National Institutes of Health; Work; acute stroke; career; cerebral hemodynamics; clinical trial enrollment; cryptogenic stroke; demographics; disability; experience; improved; innovation; medical schools; mortality; multi-ethnic; neurosurgery; next generation; patient subsets; professor; programs; screening; stroke clinical trials; stroke outcome; stroke recovery; stroke therapy; stroke trials; success; treatment center; underserved minority; working group

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 6,700 strokes in 2016. 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 August, 2017 was 375 subjects. Historically, over the last 10 years, Columbia and Cornell have been involved in 44 human stroke studies, including 29 stroke clinical trials, 10 stroke biomarker studies, and 5 stroke outcomes studies. 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. The STNCC has also provided leadership at the national level in the first 5 years of StrokeNet. Contact PI Randolph Marshall served on the NCC Executive Committee for the first 3 years, as Co-Chair of the Education and Training Core for all 5 years, and on the Recovery and Rehabilitation Working Group over the last year. He has been invited to continue the latter two roles in the upcoming renewal period. Co-I Ronald Lazar, now at UAB, served on the Recovery and Rehab WG for three years, and Co-PI E Sander Connolly has served on the Neurosurgery advisory group. In terms of innovation and clinical trial development, our RCC has the distinction of submitting and obtaining funding for two of the new StrokeNet studies. 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 5 trainees producing 22 abstracts and 21 manuscripts within 1 year of Fellowship, and 4 so far have Assistant Professor positions at major academic institutions (all StrokeNet sites). Two are applying for K-awards.

哥伦比亚和康奈尔的中风试验网络（STNCC）的主要目标是 最大限度地增加纽约中风临床试验的参与人数。哥伦比亚和康奈尔大学，位于 曼哈顿的东西两侧将分别形成两个中心，由一个Acute 布鲁克林和新泽西3家医院的治疗子网络，恢复子网络 包括韦斯特切斯特县和新泽西的2个附属学术康复中心， 以及布鲁克林和纽约西部的4个学术医疗中心。我们的枢纽和卫星 2016年治疗了6,700多例中风更重要的是，我们的RCC拥有广泛的领导力， 在中风临床试验中的记录，并有区别的是领先的登记中风 StrokeNet前5年的临床试验;截至2017年8月，我们的总入组人数为375人 科目从历史上看，在过去的10年里，哥伦比亚和康奈尔大学已经参与了44个 人类卒中研究，包括29项卒中临床试验、10项卒中生物标志物研究和5项 卒中结局研究。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15%亚洲人，圣约瑟夫24%非洲裔美国人，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。我们持有 所有区域协调中心和卫星中心的主要研究员和协调员参加每月视频会议 中心，并在RCC中进行标准化的每日卒中入院筛查。这些数据也 因为每月的视频电话会议审查试验入组情况。STNCC还 在StrokeNet的头5年里，在国家一级发挥了领导作用。联系PI兰多夫 马歇尔担任NCC执行委员会的前3年，作为联合主席， 所有5年的教育和培训核心，以及恢复和康复工作 去年一年里。他被邀请在即将到来的 更新期。Co-I罗纳德拉扎尔，现在在UAB，在恢复和康复工作组任职， 三年来，和共同PI E桑德康诺利已担任神经外科顾问组。在 在创新和临床试验开发方面，我们的RCC具有提交 并为两项新的中风网络研究获得资金。STNCC Co-Is Mitchell Elkind和 Hooman Kamel是ARCADIA试验的共同PI，这是一项多中心III期RCT，旨在确定 阿哌沙班是否上级优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，和罗纳德拉扎尔是共同PI的 CREST-H研究，CREST-2试验的辅助研究，检验以下假设： 血运重建可以改善高级别无症状患者的认知功能， 脑血流动力学衰竭的颈动脉狭窄患者。最后，我们的StrokeNet培训生计划 已取得很大成功，5名受训人员在1年内编写了22份摘要和21份手稿， 一年的奖学金，4迄今已助理教授职位，在主要学术 机构（所有StrokeNet网站）。两人申请K奖。