Blood Pressure after Endovascular Stroke Therapy-II: A Randomized Trial

血管内卒中治疗后的血压-II：随机试验

• 批准号: 10020201
• 负责人: Eva Mistry
• 金额: $ 18.65万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-17 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10020201
• 关键词: Academic Medical Centers; Acute; Affect; Applications Grants; Award; Biometry; Blinded; Blood Pressure; Blood Vessels; Blood coagulation; Blood flow; Brain; Brain Infarction; Brain Ischemia; Cerebrum; Clinical; Clinical Informatics; Clinical Trials; Clinical and Translational Science Awards; Coagulation Process; Conflict (Psychology); Critical Care; Data; Development Plans; Disabled Persons; Ensure; Environment; Etiology; Excision; Foundations; Funding; Future; Generations; Goals; Guidelines; Hemorrhage; Heterogeneity; Incidence; Inflammation; Injury; Institution; Ischemia; Ischemic Stroke; K-Series Research Career Programs; Lead; Leadership; Life; Measures; Mechanics; Mediating; Mentors; Morbidity - disease rate; Multicenter Trials; Outcome; Oxidative Stress; Patient-Focused Outcomes; Patients; Perfusion; Phase; Phase III Clinical Trials; Practice Management; Probability; Prospective cohort study; Randomized; Recovery of Function; Reperfusion Therapy; Research; Research Personnel; Research Project Grants; Research Project Summaries; Resolution; Resources; Rodent Model; Safety; Savings; Stroke; Surveys; Tennessee; Testing; Thrombectomy; Training; Translations; United States; United States National Institutes of Health; Work; acute care; acute stroke; biomedical informatics; blood pressure reduction; blood pressure regulation; brain tissue; brain volume; career; career development; clinical care; design; efficacy trial; evidence base; evidence based guidelines; functional outcomes; functional status; improved; improved outcome; informatics tool; innovation; mortality; novel; open label; phase III trial; prospective; randomized trial; restoration; safety assessment; simulation; skills; standard of care; stroke intervention; stroke patient; stroke therapy; stroke trials; success; trial design

PROJECT SUMMARY Research Project: Blood pressure (BP) management after endovascular mechanical thrombectomy (EVT) for large vessel acute ischemic stroke (AIS) can critically influence brain reperfusion, and thereby patient outcomes. Current guidelines recommend allowing higher than normal BP in the 24 hrs after an EVT without strong evidence. Our preliminary results demonstrate that lower post-EVT systolic BP (SBP) associate with better outcomes. Although low SBP targets are assumed to compromise brain perfusion, no data exist to definitely demonstrate any relationship of harm with post-EVT SBP targets. Such safety assessment of lower SBP targets is a critical prerequisite to conduct larger studies to evaluate their efficacy in improving outcomes of EVT-treated patients. We will conduct the Blood Pressure after Endovascular Stroke Therapy-II (BEST-II) trial, where 120 AIS patients successfully treated with an EVT will be randomized to three SBP targets (£180, <160, and <140 mmHg) to 1) assess the harm of lower SBP targets and 2) determine the probability (hypothesized to be ³25%) of a positive phase III efficacy trial of lower SBP targets to improve patient outcomes. To assess the harm, we will test the null hypotheses that lower SBP targets do not worsen brain ischemia or 90-day functional outcome in patients beyond a level considered safe. This proposal will generate high quality data for the planning of a large, multicenter efficacy trial. Collectively, this set of trials will lead to evidence-based guideline generation for the optimal post-EVT BP management in AIS patients. Candidate: Working close with her mentors over the past two years, Dr. Eva Mistry designed, led, and successfully completed a large, prospective, multi-institutional study (BEST-I) to demonstrate the association of improved outcomes with lower SBP in EVT-treated AIS patients. This proposal is the direct result of this preliminary work. Her long-term goal is to be a leader in novel designs and electronic facilitation of acute stroke trials to ensure efficient testing of new stroke treatments and improve patient outcomes. Career Development: To achieve her long-term goal, Dr. Mistry will follow an integrated career development plan. Her rigorous training will include coursework, personalized mentoring from mentors and advisors, and experiential training to achieve mastery in 1) trial implementation in acute and critical care settings, 2) adaptive and platform trial designs, 3) electronic facilitation of clinical trials, and 4) leadership skills. Environment: Vanderbilt University Medical Center (VUMC) is the largest comprehensive stroke center in the middle Tennessee and performs over 100 EVTs annually. As a Clinical and Translational Science Awarded institution with a large pool of NIH-funded investigators and leaders in acute and critical care clinical trials, novel trial designs, biostatistics, and clinical informatics, VUMC provides an ideal environment with myriad opportunities and support resources for Dr. Mistry to successfully accomplish her research and career goals to become an independent investigator.

项目总结 研究项目：高血压患者血管内机械取栓术(EVT)后的血压管理 大血管急性缺血性卒中(AIS)可严重影响脑再灌注，从而使患者 结果。目前的指南建议，在没有EVT的情况下，允许在EVT后24小时内血压高于正常水平 有力的证据。我们的初步结果表明，EVT后较低的收缩压(SBP)与 更好的结果。尽管低SBP目标被认为会影响脑血流灌注，但没有数据表明 明确证明任何伤害与EVT后SBP目标的关系。这样的安全评估较低 SBP目标是进行更大规模研究以评估其改善结果的有效性的关键前提 接受EVT治疗的患者。我们将测量卒中血管内治疗后的血压-II(BEST-II) 试验中，120名成功接受EVT治疗的AIS患者将随机分为三个SBP目标(GB 180， &lt；160和&lt；140毫米汞柱)以1)评估较低SBP指标的危害，以及2)确定 (假设为25%)降低SBP目标以改善患者的积极III期疗效试验 结果。为了评估危害，我们将检验降低SBP目标不会恶化大脑的无效假设 超过被认为安全的水平的患者的缺血或90天功能结局。这项提议将产生 为规划大型多中心疗效试验提供高质量的数据。总体而言，这套试验将导致 AIS患者EVT后最佳BP管理的循证指南生成。 候选人：在过去的两年里，伊娃·密斯特里博士与她的导师们密切合作，设计、领导和 成功地完成了一项大型、前瞻性、多机构研究(BEST-I)，以证明该协会 在接受EVT治疗的AIS患者中，较低的SBP改善了预后。这项提议就是这一点的直接结果 前期工作。她的长期目标是成为新设计和急性中风电子促进领域的领导者 确保有效测试新的中风治疗方法并改善患者预后的试验。 职业发展：为了实现她的长期目标，密斯特里博士将遵循一体化的职业发展 计划。她的严格培训将包括课程作业，来自导师和顾问的个性化指导，以及 体验式培训，以掌握1)在急性和危重护理环境中的试验实施，2)适应性 和平台试验设计，3)临床试验的电子促进，4)领导技能。 环境：范德比尔特大学医学中心(VUMC)是世界上最大的综合性中风中心 田纳西州中部，每年进行100多次EVT。荣获临床与翻译科学奖 该机构拥有一大批由NIH资助的研究人员和急性和危重护理临床试验的领导者， 新颖的试验设计、生物统计学和临床信息学，VUMC为无数人提供了一个理想的环境 密斯特里博士成功实现她的研究和职业目标的机会和支持资源 成为一名独立调查员。