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：
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
项目类别：
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

项目摘要

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 中风试验网络区域协调中心 (RCC) 申请 RS Marshall、ES Connolly、D Leifer、M Fink、P Stieg、联合PI 概括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提高中风临床效果位于曼哈顿西侧和东侧的纽约哥伦比亚大学和康奈尔大学的试招生，分别将形成两个中心，由布鲁克林 3 家医院组成的急性治疗子网络提供支持新泽西州，一个康复子网络，由位于新泽西州的 2 个附属学术康复中心组成威彻斯特县和新泽西州，以及布鲁克林和纽约州西部的 4 个学术医疗中心。 2022 年，我们的中心和卫星治疗了超过 8,700 例中风。更重要的是，我们的 RCC 拥有广泛的中风临床试验中的领导记录，并且是中风临床中的领先招募者 StrokeNet 前 5 年的试验；截至 2022 年 11 月，我们的总入组人数为 775 名受试者，其中包括前几年进入 StrokeNet 的试验总体上对我们的网络非常有利。招收服务不足的少数族裔：康奈尔大学有 40% 的西班牙裔和 25% 的非裔美国人； 15% 是亚洲人，圣约瑟夫医院 24% 是非裔美国人，30% 是西班牙裔，12% 是其他人。我们每月举行一次由 PI 和 PI 参加的视频会议。来自所有 RCC 中心和卫星站点的协调员，以及标准化的每日中风入院筛查 RCC 还会在每月的视频电话会议上审查这些数据和试验注册情况。为了表彰我们在临床试验入组方面的贡献，STNCC 在以下方面发挥了极其积极的领导作用：前 10 年，Randolph Marshall 博士和 Dana Leifer 博士一直是 StrokeNet Steering 的正式成员。马歇尔博士在 NCC 执行委员会任职 10 年。他还担任 NCC 执行委员会委员。教育和培训核心主席，曾担任联合主席 7 年 Ron Lazar 博士（现为 UAB），在第一年和第二年在恢复工作组任职，并由马歇尔博士继任，后来加入由 Co-I Tomoko Kitago 博士于 2021 年撰写。Connolly 博士曾在神经外科顾问小组中任职。 100%参与所有国家会议和电话会议在创新和临床试验方面。开发过程中，我们的 RCC 为两项 StrokeNet RCT 提交并获得了资金。 STNCC 联合研究员 Mitchell Elkind 和 Hooman Kamel 是 ARCADIA 试验的联合 PI，该试验是一项多中心 3 期随机对照试验确定阿哌沙班对于隐源性中风和“心房”患者是否优于标准治疗 “心脏病。”伦道夫·马歇尔、桑德·康诺利和罗纳德·拉扎尔是 CREST-H 研究的联合首席研究员。 CREST-2 试验的辅助研究，检验血运重建可以改善认知能力的假设存在脑血流动力学衰竭的高度无症状颈动脉狭窄患者的子集。最后，我们的 StrokeNet 实习生计划非常成功，11 名实习生制作了 22 份摘要获得奖学金一年内有 58 篇手稿，其中 10 人在主要学术领域担任助理教授职位机构（所有 StrokeNet 网站）有 2 个获得 K 奖，2 个获得 R01。