CTP to predict Response to recanalization in Ischemic Stroke Project (CRISP)

CTP 预测缺血性中风再通反应项目 (CRISP)

• 批准号: 8246275
• 负责人: MAARTEN G LANSBERG
• 金额: $ 62.75万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8246275
• 关键词: Accident and Emergency department; Algorithms; Benefits and Risks; Blood flow; Brain; Brain Mapping; Cerebral hemisphere hemorrhage; Cessation of life; Clinical; Clinical Data; Clinical Trials; Cohort Studies; Computer Retrieval of Information on Scientific Projects Database; Computer software; Data; Dependence; Emergency Situation; Goals; Head; Hospitals; Hour; Housing; Image; Infarction; Injury; Intervention; Ischemic Stroke; Lead; MRI Scans; Magnetic Resonance Imaging; Malignant - descriptor; Maps; Methods; Odds Ratio; Outcome; Patient Schedules; Patient Selection; Patients; Perfusion; Physicians; Population; Procedures; Process; Randomized Controlled Trials; Recruitment Activity; Reperfusion Therapy; Research; Scanning; Site; Solutions; Stroke; System; Technology; Testing; Tissues; United States; Universities; X-Ray Computed Tomography; acute stroke; base; clinical practice; cohort; design; disability; disability burden; effective therapy; experience; follow-up; inclusion criteria; programs; prospective; randomized placebo controlled trial; randomized trial; response; restoration; standard of care; tool

DESCRIPTION (provided by applicant): Stroke is the number one cause of disability in the United States. In order to reduce the burden of disability caused by stroke there is a need for better stroke treatments that are available to more stroke victims. Endovascular therapies are increasingly being used and may fill this need as they have high rates of recanalization. It is, however, not known which patients benefit clinically. Previous studies suggest that stroke patients with a small volume of irreversible ischemic injury (infarct core) and a large volume of reversible ischemic injury (penumbra) are most likely to benefit from restoration of blood flow. MRI shows promise for identification of the ischemic core and penumbra but it has very limited availability in US emergency rooms. Computed Tomography Perfusion (CTP) imaging is a potential solution as it is widely available and can easily be added to a non-contrast head CT, already routinely obtained to evaluate stroke patients in the emergency room. However, methods for processing of CTP images and criteria for interpretation of the images are still immature. Therefore, patient selection based on CTP images is not ready for implementation in clinical trials or clinical practice. The overall goal of the CTP to predict Response to recanalization in Ischemic Stroke Project (CRISP) is to develop a practical tool to identify acute stroke patients who are likely to benefit from endovascular therapy. The project has two main parts. During the first part (year 1), we propose to develop a fully automated system (RAPID) for processing of CT Perfusion (CTP) images that will generate brain maps of the ischemic core and penumbra. We will also define criteria, based on these CTP maps, which predict if a patient is likely to benefit from restoration of blood flow. These criteria will be based on data from a retrospective cohort of 95 patients treated at St Luke's hospital. During the second part (years 2-5), we aim to demonstrate that physicians in the emergency setting, with the aid of a fully automated CTP analysis program (RAPID), can accurately predict response to recanalization in stroke patients undergoing revascularization. To achieve this aim we will conduct a prospective cohort study of 100 consecutive stroke patients who will undergo a CTP scan prior to endovascular therapy. The study will be conducted at two sites (Stanford University and St Luke's Hospital). Patients will have an early follow-up scan within 6 hours to assess reperfusion and a late follow-up scan at day 5 to determine the final infarct. The successful execution of this research will provide physicians with an easy, automated method to select patients who are likely to benefit from restoration of blood flow. Such a method, thanks to easy accessibility to CT technology, would be of great value for patient selection in multi-center clinical acute stroke trials and, eventually, in routine clinical practice. PUBLIC HEALTH RELEVANCE: The key objective of the CTP to predict Response to recanalization in Ischemic Stroke Project (CRISP) is to obtain sufficient preliminary data to optimally design a definitive study to assess the risks and benefits of new stroke treatments aimed at restoration of blood flow. We believe that CRISP will clarify that specific CT perfusion findings can identify patients who are likely to benefit from restoration of blood flow to the brain. These findings will eventually lead to effective therapies for a large population of stroke patients who are currently ineligible for treatment and substantially reduce stroke-related disability.

描述（由申请人提供）：中风是美国残疾的第一原因。为了减轻中风造成的残疾负担，需要更好的中风治疗，而中风受害者可以使用。血管内疗法越来越多地被使用，并且可能会满足这种需求，因为它们具有很高的再通效率。但是，尚不清楚哪些患者在临床上受益。 先前的研究表明，少量不可逆性缺血性损伤（梗塞核心）和大量可逆的缺血性损伤（Penumbra）的中风患者最有可能受益于恢复血流。 MRI显示出识别缺血性核心和半阴茎的希望，但在美国急诊室的可用性非常有限。计算机断层扫描灌注（CTP）成像是一种潜在的解决方案，因为它可以广泛使用，并且可以轻松地添加到非对比度的头部CT中，并已常规获得以评估急诊室中的中风患者。但是，处理CTP图像的方法和图像解释的标准仍然不成熟。因此，基于CTP图像的患者选择还没有准备好在临床试验或临床实践中实施。 CTP预测缺血性卒中项目（CRISP）对重新定性反应的总体目标是开发一种实用的工具来鉴定可能从血管内治疗中受益的急性中风患者。 该项目有两个主要部分。在第一部分（第1年）中，我们建议开发一个完全自动化的系统（快速）来处理CT灌注（CTP）图像，该图像将生成缺血性核心和阴茎的大脑图。我们还将根据这些CTP图来定义标准，这些标准可以预测患者是否可能受益于血液流量的恢复。这些标准将基于来自圣卢克医院接受治疗的95例患者的回顾性队列的数据。在第二部分（2 - 5年）中，我们旨在证明紧急情况下的医生在完全自动化的CTP分析计划（快速）的帮助下，可以准确预测接受血运重建的中风患者重新定性的反应。为了实现这一目标，我们将对100名连续中风患者进行前瞻性队列研究，这些患者将在血管内治疗之前接受CTP扫描。该研究将在两个地点（斯坦福大学和圣卢克医院）进行。患者将在6小时内进行早期随访，以评估再灌注并在第5天进行较晚的随访扫描，以确定最终梗塞。 这项研究的成功执行将为医生提供一种简单，自动化的方法，以选择可能从恢复血液中受益的患者。由于对CT技术的易于访问，这种方法对于在多中心临床急性中风试验中的患者选择以及最终在常规临床实践中最终具有巨大的价值。 公共卫生相关性：CTP预测缺血性中风项目（CRISP）对重新加续化的反应的关键目标是获得足够的初步数据，以最佳设计一项确定的研究，以评估旨在恢复血流的新中风治疗的风险和好处。我们认为Crisp会澄清，特定的CT灌注结果可以鉴定出可能从恢复血液流向大脑的患者。这些发现最终将为大量中风患者提供有效的疗法，这些患者目前不符合治疗并大大减少与中风相关的残疾。