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

Award Number: K23NS113858
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 09/17/2019
PERIOD OF PERFORMANCE END DATE: 12/31/2023

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$120,586 )
2025	2023	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	11/15/2024	NON-COMPETING CONTINUATION	$0
2025	2023	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	6	11/20/2024	NON-COMPETING CONTINUATION	-$120,586
														Subtotal = -$120,586

Issue Date FY: 2023 ( Subtotal = $166,838 )
2023	2023	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	6	8/1/2023	NON-COMPETING CONTINUATION	$166,838
2023	2021	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	10/28/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$368
2023	2020	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	10/28/2022	NON-COMPETING CONTINUATION	-$368
														Subtotal = $166,838

Issue Date FY: 2022 ( Subtotal = $176,635 )
2022	2022	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	5	7/29/2022	NON-COMPETING CONTINUATION	$176,635
2022	2021	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	3/23/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$15,641
2022	2020	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	3/23/2022	NON-COMPETING CONTINUATION	-$15,641
														Subtotal = $176,635

Issue Date FY: 2021 ( Subtotal = $185,436 )
2021	2021	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	3	8/2/2021	NON-COMPETING CONTINUATION	-$185,436
2021	2021	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	6/11/2021	NON-COMPETING CONTINUATION	$185,436
2021	2021	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	4	8/2/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$185,436
														Subtotal = $185,436

Issue Date FY: 2020 ( Subtotal = $186,516 )
2020	2020	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	6/24/2020	NON-COMPETING CONTINUATION	$186,516
														Subtotal = $186,516

Issue Date FY: 2019 ( Subtotal = $185,436 )
2019	2019	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	9/27/2019	NEW	$0
2019	2019	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/17/2019	NEW	$185,436
														Subtotal = $185,436

Grand Total All Awards = $780,275

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

Award Number: K23NS113858

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 09/17/2019

PERIOD OF PERFORMANCE END DATE: 12/31/2023

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