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: 10457181
• 负责人: Eva Mistry
• 金额: $ 18.54万
• 依托单位: UNIVERSITY OF CINCINNATI
• 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/10457181
• 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 evaluation; 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.

项目摘要 研究项目：血压（BP）在血管内机械血栓切除术（EVT）之后的管理 大血管急性缺血性中风（AIS）可以严重影响大脑再灌注，从而患者 结果。当前的指南建议在没有EVT之后的24小时内允许高于正常BP 有力的证据。我们的初步结果表明，较低的evt后收缩BP（SBP）与 尽管假定低SBP靶标会损害大脑灌注，但没有任何数据 绝对证明了与EVT后SBP目标的任何危害关系。此类安全评估较低 SBP目标是进行大型研究以评估其改善预后效率的关键先决条件 EVT治疗的患者。我们将在血管内中风疗法II（BEST-II）后进行血压 试验，其中120名通过EVT治疗的AIS患者将被随机分为三个SBP目标（180英镑， <160，<140 mmHg）至1）评估较低SBP目标的危害，2）确定概率 （假设为25％）在较低的SBP靶标有效试验中，以改善患者 结果。为了评估危害，我们将测试较低的SBP靶标的无效假设 超过一个被认为是安全的患者的缺血或90天功能结果。该建议将产生 大型多中心效率试验计划的高质量数据。总的来说，这套试验将导致 AIS患者最佳EVT BP管理的基于证据的指南生成。 候选人：在过去两年中与她的导师密切合作，Eva Mistry博士设计，LED和 成功完成了一项大型，前瞻性的多机构研究（BEST-I），以证明该协会 在EVT治疗的AIS患者中，SBP较低的结果改善。该提议是此提案的直接结果 她的长期目标是成为急性中风的新颖设计和电子设施的领导者 试验，以确保对新中风治疗的有效测试并改善患者预后。 职业发展：为了实现她的长期目标，Mistry博士将遵循综合的职业发展 计划。她严格的培训将包括课程工作，导师和顾问的个性化指导以及 在1）急性和重症监护环境中的试验实施中实现经验训练，2）自适应 和平台试验设计，3）临床试验的电子准备，以及4）领导技能。 环境：范德比尔特大学医学中心（VUMC）是最大的综合中风中心 田纳西州中部每年进行100多次EVT。作为一门临床和转化科学 急性和重症监护临床试验中有大量NIH资助的研究人员和领导人的机构， 新型试验设计，生物统计学和临床​​信息，VUMC提供了无数的理想环境 机会和支持Mistry博士成功实现她的研究和职业目标的资源 成为独立研究者。