Biomarkers of Acute Stroke Etiology (BASE) Study Methodology

Translational Stroke Research, May 2017

Acute ischemic stroke affects over 800,000 US adults annually, with hundreds of thousands more experiencing a transient ischemic attack. Emergent evaluation, prompt acute treatment, and identification of stroke or TIA (transient ischemic attack) etiology for specific secondary prevention are critical for decreasing further morbidity and mortality of cerebrovascular disease. The Biomarkers of Acute Stroke Etiology (BASE) study is a multicenter observational study to identify serum markers defining the etiology of acute ischemic stroke. Observational trial of patients presenting to the hospital within 24 h of stroke onset. Blood samples are collected at arrival, 24, and 48 h later, and RNA gene expression is utilized to identify stroke etiology marker candidates. The BASE study began January 2014. At the time of writing, there are 22 recruiting sites. Enrollment is ongoing, expected to hit 1000 patients by March 2017. The BASE study could potentially aid in focusing the initial diagnostic evaluation to determine stroke etiology, with more rapidly initiated targeted evaluations and secondary prevention strategies. Clinical Trial Registration Clinicaltrials.​gov NCT02014896 https://​clinicaltrials.​gov/​ct2/​show/​NCT02014896?​term=​biomarkers+of+ac​ute+stroke+etiol​ogy&​rank=​1

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Biomarkers of Acute Stroke Etiology (BASE) Study Methodology

Transl. Stroke Res. Biomarkers of Acute Stroke Etiology (BASE) Study Methodology Edward C. Jauch 0 1 2 3 4 6 7 9 10 Andrew D. Barreto 0 1 2 3 4 6 7 9 10 Joseph P. Broderick 0 1 2 3 4 6 7 9 10 Doug M. Char 0 1 2 3 4 6 7 9 10 Brett L. Cucchiara 0 1 2 3 4 6 7 9 10 Thomas G. Devlin 0 1 2 3 4 6 7 9 10 Alison J. Haddock 0 1 2 3 4 6 7 9 10 William J. Hicks 0 1 2 3 4 6 7 9 10 Brian C. Hiestand 0 1 2 3 4 6 7 9 10 Glen C. Jickling 0 1 2 3 4 6 7 9 10 Jeff June 0 1 2 3 4 6 7 8 9 10 David S. Liebeskind 0 1 2 3 4 6 7 9 10 Ted J. Lowenkopf 0 1 2 3 4 5 6 7 9 10 Joseph B. Miller 0 1 2 3 4 6 7 9 10 John O'Neill 0 1 2 3 4 6 7 9 10 Tim L. Schoonover 0 1 2 3 4 6 7 9 10 Frank R. Sharp 0 1 2 3 4 6 7 9 10 W. Frank Peacock 0 1 2 3 4 6 7 9 10 0 University of Pennsylvania , Pittsburgh, PA , USA 1 Washington University , St. Louis, MO , USA 2 University of Cincinnati , Cincinnati, OH , USA 3 Allegheny Medical Center , Pittsburgh, PA , USA 4 Henry Ford Hospital , Detroit, MI , USA 5 Providence Brain and Spine Institute , Portland, OR , USA 6 University of California , Los Angeles, CA , USA 7 Clinical Trial Registration Clinicaltrials.gov NCT02014896 https://clinicaltrials.gov/ ct2/show/NCT02014896?term=biomarkers 8 Ischemia Care, LLC , Cincinnati, OH , USA 9 Baylor College of Medicine , 3302 S. Macgregor Way, Houston, TX 77021 , USA 10 Erlanger Health System , Chattanooga, TN , USA Acute ischemic stroke affects over 800,000 US adults annually, with hundreds of thousands more experiencing a transient ischemic attack. Emergent evaluation, prompt acute treatment, and identification of stroke or TIA (transient ischemic attack) etiology for specific secondary prevention are critical for decreasing further morbidity and mortality of cerebrovascular disease. The Biomarkers of Acute Stroke Etiology (BASE) study is a multicenter observational study to identify serum markers d e f i n i n g t h e e t i o l o g y o f a c u t e i s c h e m i c s t r o k e . Observational trial of patients presenting to the hospital within 24 h of stroke onset. Blood samples are collected at arrival, 24, and 48 h later, and RNA gene expression is utilized to identify stroke etiology marker candidates. The BASE study began January 2014. At the time of writing, there are 22 recruiting sites. Enrollment is ongoing, expected to hit 1000 patients by March 2017. The BASE study could potentially aid in focusing the initial diagnostic evaluation to determine stroke etiology, with more rapidly initiated targeted evaluations and secondary prevention strategies. Acute Stroke; RNA expression; Biomarkers - Medical University of South Carolina, Charleston, SC, USA University of Texas, Houston, TX, USA Introduction Acute ischemic stroke (AIS) remains a leading cause of mortality and morbidity in the USA, affecting over 800,000 adults annually and leaving many with permanent disability [1]. Furthermore, hundreds of thousands of Americans experience a transient ischemic attack which often precedes a major stroke and serves as a warning for future ischemic events [2]. Despite resolved symptoms, experiencing a TIA (transient ischemic attack) is associated with a stroke risk of up to 20% within 90 days. Collectively, previous stroke and TIA confer an annual recurrent stroke risk of 3–4% [1]. Emergent evaluation, prompt acute treatment, and identification of stroke or 8 9 10 12 14 OhioHealth Riverside Methodist Hospital, Columbus, OH, USA Wake Forest, School of Medicine, Winston-Salem, NC, USA University of California, Davis, Sacramento, CA, USA TIA etiology for specific secondary prevention are critical for decreasing further morbidity and mortality of cerebrovascular disease [2]. Key to secondary prevention is stroke etiology identification. This is because the stroke etiology determines which treatment is most effective to prevent future strokes. In addition to risk factor modification for all patients with stroke or TIA, anticoagulant therapy is indicated for cardioembolic stroke. This is in contradistinction to atherogenic strokes where antiplatelet agents are recommended. Currently, the diagnosis of ischemic stroke etiology is determined from a combination of patient history, clinical assessment, cerebrovascular imaging, and cardiovascular evaluation. However, even with extensive testing, identifying the cause of an acute stroke is challenging. Strokes of unclear etiology, or cryptogenic strokes, represent a significant risk as optimal prevention measures cannot be identified. Therefore, there is a great need to identify the pathogenesis of acute ischemic stroke in order to implement targeted and effective preventative measures. Recent studies have suggested whole blood RNA expression may help differentiate ischemic stroke mechanisms [ 3–7 ].The Biomarkers of Acute Stroke Etiology (BASE) study (NCT02014896) is a multicenter observational study utilizing RNA gene expression to identify the etiology of acute ischemic stroke. When a stroke or TIA occurs, the immune system (...truncated)


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Edward C. Jauch, Andrew D. Barreto, Joseph P. Broderick, Doug M. Char, Brett L. Cucchiara, Thomas G. Devlin, Alison J. Haddock, William J. Hicks, Brian C. Hiestand, Glen C. Jickling, Jeff June, David S. Liebeskind, Ted J. Lowenkopf, Joseph B. Miller, John O’Neill, Tim L. Schoonover, Frank R. Sharp, W. Frank Peacock. Biomarkers of Acute Stroke Etiology (BASE) Study Methodology, Translational Stroke Research, 2017, pp. 424-428, Volume 8, Issue 5, DOI: 10.1007/s12975-017-0537-3