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.

项目总结