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

基本信息

批准号：
10468292
负责人：
EDWARD SANDER CONNOLLY
金额：
$ 31.18万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-15 至 2023-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10468292
关键词：
Academic Medical Centers Acute Admission activity Adult African American Ancillary Study Area Asian Biological Markers Carotid Stenosis Childhood stroke Clinical Clinical Research Clinical Trials Cognition County Data Development Disease Enrollment Failure Fellowship Funding Goals Heart Atrium Hispanic 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

项目摘要

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.

哥伦比亚和康奈尔大学中风试验网络 (STNCC) 的主要目标是最大限度地增加纽约哥伦比亚大学和康奈尔大学的中风临床试验注册人数。曼哈顿西侧和东侧将分别形成两个枢纽，并由急性布鲁克林和新泽西州 3 家医院的治疗子网、康复子网包括位于威彻斯特县和新泽西州的 2 个附属学术康复中心，以及位于布鲁克林和纽约西部的 4 个学术医疗中心。 2016 年治疗了超过 6,700 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创下记录，并成为中风领域的领先入组者 StrokeNet 前 5 年的临床试验；截至 2017 年 8 月，我们的总注册人数为 375 人从历史上看，在过去 10 年里，哥伦比亚大学和康奈尔大学已参与了 44 个课题。人类中风研究，包括 29 项中风临床试验、10 项中风生物标志物研究和 5 项中风研究我们网络中的总体人口统计数据非常有利于中风结果研究。招收服务不足的少数族裔：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% 亚裔；圣约瑟夫学院 24% 非裔美国人，30% 西班牙裔，12% 其他我们的成功部分归功于我们拥有高度组织和互动的基础设施。来自所有 RCC 中心和卫星的 PI 和协调员参加的每月视频会议 RCC 的每日标准化中风入院筛查以及这些数据。 STNCC 还会在每月的视频电话会议上审查试用注册情况。在 StrokeNet 的前 5 年里，他在国家层面发挥了领导作用。联系 PI Randolph。马歇尔在 NCC 执行委员会的前 3 年担任委员会联合主席为期五年的教育和培训核心，以及康复和康复工作去年，他被邀请在即将到来的年度继续担任后两个角色。续约期间，罗纳德·拉扎尔 (Ronald Lazar) 中尉现就职于 UAB，曾在恢复和康复工作组任职。三年来，Co-PI E Sander Connolly 曾在神经外科咨询小组任职。在创新和临床试验开发方面，我们的RCC具有提交并为 STNCC 的两项新研究获得资金 Mitchell Elkind 和 Hooman Kamel 是 ARCADIA 试验的联合 PI，该试验是一项多中心 3 期随机对照试验，旨在确定对于隐源性卒中和“心房”患者，阿哌沙班是否优于标准治疗伦道夫·马歇尔、桑德·康诺利和罗纳德·拉扎尔是该项目的联合 PI。 CREST-H 研究是 CREST-2 试验的辅助研究，检验以下假设：血运重建可以改善部分高度无症状患者的认知能力最后，我们的 StrokeNet 实习生计划。取得了巨大成功，5 名学员在 1 年内创作了 22 篇摘要和 21 篇手稿年度研究员，迄今为止已有 4 人在主要学术领域担任助理教授职位机构（所有 StrokeNet 网站）正在申请 K 奖。