Biomarkers of Acute Stroke Etiology (BASE) Study Methodology

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, 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

Abstract

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://ichgcp.net/clinical-trials-registry/NCT02014896?term=biomarkers+of+acute+stroke+etiology&rank=1.

Keywords: Acute Stroke; Biomarkers; RNA expression.

Conflict of interest statement

Funding

This study was funded by Ischemia Care, LLC, Oxford, OH, USA.

Conflict of Interest

Edward C. Jauch: research grant support from Ischemia Care, LLC

Andrew D. Barretto: none

Joseph P. Broderick: none

Doug M. Char: research grant support from Ischemia Care, LLC

Brett L. Cucchiara: research grant support from Ischemia Care, LLC

Thomas G. Devlin: none

Alison J. Haddock: research grant support from Ischemia Care, LLC

William J. Hicks: none

Brian C. Hiestand: research grant support from Ischemia Care, LLC

Glen C. Jickling: none

Jeff June: ownership interest in Ischemia Care, LLC, sponsor of the trial

David S. Liebeskind: none

Ted J. Lowenkopf: none

Joseph B. Miller: research grant support from Ischemia Care, LLC

John O’Neill: research grant support from Ischemia Care, LLC

Tim L. Schoonover: none

Frank R. Sharp: none

W. Frank Peacock: stock owner in Ischemia Care, LLC

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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Source: PubMed

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