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

描述（由申请人提供）：中风是美国第一大致残原因。为了减轻中风造成的残疾负担，有必要为更多的中风患者提供更好的中风治疗。由于血管内治疗具有较高的再通率，因此越来越多地应用于血管内治疗。然而，尚不清楚哪些患者在临床上受益。以往的研究表明，小容量不可逆缺血性损伤（梗死核心）和大容量可逆性缺血性损伤（半暗带）的脑卒中患者最有可能从血流恢复中获益。MRI显示有希望识别缺血核心和半暗带，但它在美国急诊室的可用性非常有限。计算机断层扫描灌注成像（CTP）是一种潜在的解决方案，因为它广泛可用，可以很容易地添加到非对比头部CT上，已经在急诊室常规评估中风患者。然而，CTP图像的处理方法和解译标准尚不成熟。因此，基于CTP图像的患者选择还不适合在临床试验或临床实践中实施。CTP预测缺血性卒中再通反应项目（CRISP）的总体目标是开发一种实用的工具，以识别可能从血管内治疗中获益的急性卒中患者。该项目有两个主要部分。在第一部分（第一年），我们建议开发一个全自动系统（RAPID）来处理CT灌注（CTP）图像，该图像将生成缺血核心和半暗带的脑图。我们还将根据这些CTP图定义标准，以预测患者是否可能从血流恢复中受益。这些标准将基于在圣卢克医院接受治疗的95名患者的回顾性队列数据。在第二部分（2-5年），我们的目标是证明急诊医生在全自动CTP分析程序（RAPID）的帮助下，可以准确预测接受血运重建术的脑卒中患者对再通的反应。为了实现这一目标，我们将对100例连续卒中患者进行前瞻性队列研究，这些患者将在血管内治疗前接受CTP扫描。这项研究将在两个地点进行（斯坦福大学和圣卢克医院）。患者将在6小时内进行早期随访扫描以评估再灌注，并在第5天进行晚期随访扫描以确定最终梗死。这项研究的成功实施将为医生提供一种简单、自动化的方法来选择可能从血流恢复中受益的患者。由于CT技术的易用性，这种方法对于多中心急性脑卒中临床试验的患者选择以及最终的常规临床实践具有重要价值。

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.