Interventional Management of Stroke Phase III Trial - SDCC

中风介入治疗 III 期试验 - SDCC

基本信息

批准号：
8696958
负责人：
Yuko Y Palesch
金额：
$ 25.45万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-30 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8696958
关键词：
Acute Adverse event Alberta province Alteplase Angiography Biometry Case Report Form Cerebral Infarction Clinical Clinical Data Clinical Management Clinical Trials Clinical Trials Data Monitoring Committees Coagulation Process Data Data Aggregation Data Coordinating Center Data Quality Databases Device Removal Devices Diagnostic Procedure Doctor of Philosophy Effectiveness Enrollment Epidemiology Excision FDA approved Grant Health Health Policy Hematoma Hospitalization Hour Image Infarction Internal carotid artery structure Intracranial Hemorrhages Intravenous Ischemic Stroke Leadership Length of Stay Lesion Magnetic Resonance Angiography Manuscripts Measures Medical Monitor National Institute of Neurological Disorders and Stroke Oral Outcome Outcome Measure Outpatients Patients Pharmaceutical Preparations Phase III Clinical Trials Procedures Process Public Health Randomized Rehabilitation therapy Relative (related person)Reporting Research Personnel Resources Safety Site South Carolina Specific qualifier value Stroke System Thrombus Trail Making Test U-Series Cooperative Agreements United States National Institutes of Health Universities Visit Work X-Ray Computed Tomography acute stroke artery occlusion basilar artery clinical practice cost cost effectiveness data management flexibility high standard implementation trial improved indexing middle cerebral artery mortality payment posters programs protocol violation screening standard care thrombolysis treatment duration trial comparing

项目摘要

DESCRIPTION (provided by applicant): The clinical practice of acute ischemic stroke is at a critical juncture. The use of dot-removal devices approved by the FDA is rapidly expanding, and more devices are poised to enter clinical practice in next several years. This major change in clinical practice has accelerated since 2004 after the approval of the first FDA-cleared device for thrombus removal in acute stroke patients and is occurring without clinical data demonstrating that these devices improve patient outcome as compared to standard therapy (IV rt-PA within three hours of onset). The ongoing multicenter Interventional Management of Stroke (IMS) III Trial is the only randomized Phase III trial that compares the standard therapy to an approach that combines IV rt-PA followed by lA removal of thrombus by devices and/or lA rt-PA. Data from this Trial are critical to inform clinical and public health policy decisions regarding the roe of endovascular therapy for acute ischemic stroke. The primary objective of the IMS III Trial is to determine if ischemic stroke subjects with a baseline NIHSS scores 10, or with an NIHSSSof 8-9 with evidence of MCA, ICA, or basilar artery occlusion by CTA, treated with the combined IV+IA approach started within 3 hours of onset, are more likely to have a favorable outcome, defined as a modified Rankin Scale score of 0-2 assessed at 90 days from randomization, as compared to subjects treated with standard IV rt-PA. The two treatment groups also are compared with regard to additional clinical outcome measures, imaging, and safety data. In addiiton, cost effectiveness of the combined IV+IA approach is evaluated. The Trial currently is supported by two NINDS cooperative agreement grants: (1) to the University of Cincinnati Clinical Coordinating and Angiographic Imaging Center (PI: Joseph P. Broderick, MD) to provide clinical leadership and project and site management; and (2) to the Statistical and Data Coordinating Center (SDCC) at the Medical University of South Carolina (PI: Yuko Y. Palesch, PhD) to provide data management and statistical expertise. The purpose of this competitive renewal application from the SDCC is to closely collaborate with the Trial investigators to bring the IMS III Trial to successful completion with data quality of the highest standard.

描述（申请人提供）：急性缺血性脑卒中的临床实践正处于关键时刻。 FDA 批准的去斑设备的使用正在迅速扩大，未来几年将有更多设备进入临床实践。自 2004 年第一个 FDA 批准的治疗设备获得批准以来，临床实践的这一重大变化加速了急性中风患者的血栓清除术正在发生，但没有临床数据证明这些设备与标准疗法（发病后三小时内静脉注射 rt-PA）相比可以改善患者的预后。正在进行的多中心中风介入治疗 (IMS) III 试验是唯一一项随机 III 期试验，该试验将标准疗法与 IV rt-PA 结合使用装置和/或 lA rt-PA 去除血栓的方法进行比较。该试验的数据对于为急性缺血性卒中血管内治疗的临床和公共卫生政策决策提供信息至关重要。 IMS III 试验的主要目标是确定基线 NIHSS 评分为 10 的缺血性卒中受试者，或 NIHSSS 为 8-9 且有 MCA、ICA 或 CTA 证据显示基底动脉闭塞的缺血性卒中受试者，在发病 3 小时内开始采用 IV+IA 联合方法治疗，是否更有效与接受标准 IV rt-PA 治疗的受试者相比，可能会产生有利的结果，定义为随机化后 90 天评估的改良 Rankin 量表评分为 0-2。还比较了两个治疗组的其他临床结果指标、影像学和安全性数据。此外，还评估了 IV+IA 组合方法的成本效益。该试验目前得到两项 NINDS 合作协议拨款的支持：(1) 辛辛那提大学临床协调和血管造影成像中心（PI：Joseph P. Broderick，医学博士）提供临床领导以及项目和现场管理； (2) 南卡罗来纳医科大学统计和数据协调中心 (SDCC)（首席研究员：Yuko Y. Palesch 博士）提供数据管理和统计专业知识。 SDCC 提出这一竞争性更新申请的目的是与试验研究人员密切合作，以最高标准的数据质量成功完成 IMS III 试验。