Biomarkers of Acute Stroke Etiology (BASE) Study Methodology

Edward C Jauch,Joseph P Broderick,Andrew D Barreto,Joseph B Miller,Brett L Cucchiara,David S Liebeskind,Thomas G Devlin,Jeff June,Doug M Char,Alison J Haddock,John O’Neill,Ted J Lowenkopf,Brian C Hiestand,Frank R Sharp,Tim L Schoonover,William J Hicks,W Frank Peacock,Glen C Jickling

doi:10.1007/s12975-017-0537-3

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 RegistrationClinicaltrials.gov NCT02014896 https://clinicaltrials.gov/ct2/show/NCT02014896?term=biomarkers+of+acute+stroke+etiology&rank=1

Highlights

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]
This is in contradistinction to atherogenic strokes where antiplatelet agents are recommended
This manuscript describes the methodology employed in the Biomarkers of Acute Stroke Etiology (BASE) study to identify stroke etiology in patients presenting with acute stroke

Summary

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]. In addition to risk factor modification for all patients with stroke or TIA, anticoagulant therapy is indicated for cardioembolic stroke. The Ischemia Care diagnostic platform consists of whole blood biomarker tests to determine the etiology of ischemic stroke (ISCDX, Blue Ash, OH) by measuring acute ischemic stroke gene expression changes. The ISCDX test distinguishes between cardioembolic and large artery, as well as lacunar, atherosclerotic stroke using a signature of 40 unique genes. A patient’s pattern of gene regulation can determine if the stroke etiology is that of a cardioembolic or large artery atherosclerotic source. The primary objective of the BASE study is to confirm the diagnostic accuracy of the ISCDX test to identify stroke subtypes in patients with acute ischemic stroke. This manuscript describes the methodology employed in the BASE study to identify stroke etiology in patients presenting with acute stroke

Methods

Findings

Summary