Hypothermia in Acute Stroke with Thrombolysis Imaging Evaluation of Revasculariza

急性脑卒中低体温与血运重建的溶栓影像学评估

基本信息

批准号：
8536969
负责人：
DAVID SIGMUND LIEBESKIND
金额：
$ 52.79万
依托单位：
UNIVERSITY OF CALIFORNIA LOS ANGELES
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-01 至 2015-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8536969
关键词：
Acute Address Adult Advanced Development Alteplase Ancillary Study Angiography Arteries Benchmarking Biological Markers Biology Blood - brain barrier anatomy Blood flow Brain Clinical Clinical Trials Confounding Factors (Epidemiology)Data Development Enrollment Ensure Evaluation Functional disorder Funding Future Goals Growth Health Hemorrhage Hour Human Image Image Analysis Imaging Device Imaging Techniques Infarction Injury Intravenous Investigation Investments Ischemic Stroke Knowledge Laboratories Leadership Lesion Magnetic Resonance Imaging Measures Middle Cerebral Artery Infarction Myocardial Infarction Neurological outcome Outcome Outcome Measure Parents Patients Perfusion Permeability Phase Population Process Property Public Health Relative (related person)Reperfusion Therapy Research Research Infrastructure Research Personnel Safety Site Stroke Testing Therapeutic Time Translations United States National Institutes of Health acute stroke arm base disability experience improved innovation insight middle cerebral artery natural hypothermia nervous system disorder neuroprotection pre-clinical prospective response restoration socioeconomics success thrombolysis

项目摘要

DESCRIPTION (provided by applicant): Hypothermia in Acute Stroke with Thrombolysis Imaging Evaluation of Revascularization (HASTIER) is a focused ancillary imaging study to the Intravascular Cooling in the Treatment of Stroke 2 (ICTuS 2) trial, an ongoing, NIH-funded project on the safety and efficacy of hypothermia combined with thrombolysis. The objective of HASTIER is to address established preclinical concerns that hypothermia impairs recanalization and reperfusion with standard thrombolytic treatment with intravenous (IV) tissue plasminogen activator (tPA) for acute ischemic stroke in humans. Our hypothesis is that hypothermia does not impair either recanalization (opening of the artery) or reperfusion (restoration of downstream flow) with thrombolysis. This prospective, ancillary study of 120 ICTuS 2 subjects with middle cerebral artery stroke over 2 years uses an innovative imaging approach with multimodal CT/MRI to seamlessly evaluate these distinct aspects of revascularization. The relative impact of recanalization (CTA/MRA from baseline to 36 hours in Specific Aim 1) and reperfusion (CT/MR perfusion from baseline to 36 hours and imaging correlates of reperfusion such as hemorrhage and infarct growth in Specific Aim 2) may be impossible to predict or decipher without imaging as proposed in this study. Hypothermia and thrombolysis each offer potential benefit to improve stroke outcome, yet the concern regarding impaired thrombolysis during hypothermia may impede further translation. HASTIER uses an experienced core lab and expertise from landmark stroke imaging trials to test hypothermic thrombolysis against established revascularization benchmarks. HASTIER outcomes in Specific Aims 1 and 2 will provide distinct, yet complementary data essential to future development of combined hypothermia and thrombolysis with IV tPA. HASTIER imaging outcomes for recanalization and reperfusion may be extremely valuable irrespective of ICTuS 2 results, identifying the mechanisms that drive neurological outcomes and advancing other studies of revascularization beyond hypothermic thrombolysis. The expertise and infrastructure for this short, focused study of concrete scientific objectives will enhance the NIH investment in ICTuS 2, expanding knowledge on revascularization for acute stroke in humans and the impact of hypothermia.

描述（由申请人提供）：急性中风的低温和血栓化成像评估血运重建评估（HASTIE）是一项重点的辅助成像研究，可用于治疗中风2（ICTUS 2）试验的血管内冷却，这是一项持续的，NIH资助的项目，该项目涉及与溶解疗法的安全性和效率。 HASTIE的目的是解决确定的临床前关注点，即低温损害并通过静脉溶解（IV）组织纤溶酶原激活剂（TPA）损害标准溶栓治疗的再融化和再灌注，以使人类的急性缺血性中风。我们的假设是，体温过低不会损害重新定性（动脉的开放）或通过溶栓的再灌注（下游流动的恢复）。这项对120个ICTUS 2受试者的前瞻性辅助研究在2年内具有中风中风中风的中风，使用了具有多模式CT/MRI的创新成像方法，以无缝评估血运重建的这些不同方面。重新定性的相对影响（在特定目标中从基线到36小时的CTA/MRA 1）和再灌注（从基线到36小时的CT/MR灌注以及再灌注的成像相关性，例如特定目标中的出血和梗死生长等相关性2）可能无法预测或破坏这项研究，因此无法预测或破译。体温过低和溶栓分解都为改善中风结果提供了潜在的好处，但是在体温过低期间溶栓受损的关注可能会阻碍进一步的翻译。 Hastier使用具有里程碑意义的中风成像试验中经验丰富的核心实验室和专业知识来测试针对已建立的血运重建基准测试的低温溶栓。特定目的1和2中的进展将为未来的体温过低和IV TPA的综合发展提供独特但互补的数据。不管ICTUS 2的结果如何，迅速成像的结局和再灌注的结果可能非常有价值，从而确定了驱动神经学结果的机制，并推进了超出低温溶栓的其他血运重建研究。这项对具体科学目标的简短，重点研究的专业知识和基础设施将增强对ICTUS 2的NIH投资，扩大人类急性中风血运重建知识以及体温过低的影响。