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Healthcare Professionals

Ischemia Care Overview for Healthcare Professionals

Over fifteen years of Federally funded peer reviewed research created the foundation for Ischemia Care's testing and intellectual property. Early clinical data demonstrated unique patterns of gene activity measured in RNA isolated from whole blood, known as gene expression, changed in response to a stroke and could be used to uniquely identify cause.

Ischemia Care was founded in 2009 and licensed multiple pieces of intellectual property related to RNA expression and stroke. The company also obtained the original samples from the early discoveries and validated to the original discoveries in 2012 in the Ischemia Care CLIA laboratory.

Ischemia Care then worked with leaders in the field of stroke to design the BASE clinical trial.

BASE clinical trial (NCT02014896)

The Biomarkers of Acute Stroke Etiology (BASE) study (NCT02014896) is a multicenter observational study utilizing RNA gene expression in to identify the etiology of acute ischemic stroke. When a stroke or TIA occurs, the immune system reacts by changes in gene expression in multiple cell lines, related to activation of innate and adaptive immune systems. BASE enrolled it’s first subject in 2014 and was the fastest enrolling and most successful stroke biomarker clinical trial in history, driven by clinicians dedicated to improving stroke care.

For more information on BASE please see:

  1. Biomarkers of Acute Stroke Etiology (BASE) Study Methodology, Jauch, E.C., Barreto, A.D., Broderick, J.P. et al. Transl. Stroke Res. (2017) 8: 424. https://doi.org/10.1007/s12975-017-0537-3.

  2. ClinicalTrials.gov listing for BASE (https://clinicaltrials.gov/ct2/show/NCT02014896)

  3. Please see the 2018 video

Significant peer reviewed published research

Previous studies have suggested that differential gene expression is a function of stroke subtype. Thus each test provides a "signature" of genes in which each is uniquely expressed from different stroke etiologies. Please see listing at bottom of this page for additional publications.

Ischemia Care testing is based on stroke mechanisms in blood

Ischemic stroke, in most cases, is a disease of the vasculature and blood, involving platelets, red blood cells, clotting factors, inflammatory cells, and endothelium. In simple terms, blood can provide a window into the mechanisms that cause stroke.

Ischemic stroke and secondary prevention

Acute ischemic stroke (AIS) remains a leading cause of mortality and morbidity in the United States, affecting over 800,000 adults annually, leaving many with permanent disability.

Furthermore, hundreds of thousands of Americans experience a transient ischemic attack (TIA) which often precedes a major stroke and serves as a warning for future ischemic events. Despite symptoms resolving, experiencing a TIA increases the risk of stroke by 20% within 90 days. Collectively, previous stroke and TIA confer an annual recurrent stroke risk of 3-4%.

Emergent evaluation, prompt acute treatment, and identification of stroke or TIA etiology for secondary prevention are necessary to decreasing the morbidity and morality of cerebrovascular disease.

Cryptogenic stroke is a stroke of unknown cause

The most common causes of ischemic stroke are large-artery artherosclerosis, cardioembolism, small-vessel disease, other known causes, and cryptogenic. Cryptogenic strokes, or due to unknown cause, account for 10 to 40% of all ischemic strokes. Roughly 30-40% of first time strokes are cryptogenic. It is necessary to establish the cause of stroke to select appropriate preventative care.

Secondary prevention differs by cause

Key to treatment and prevention is the identification of stroke etiology, since secondary prevention measures differ base d on stroke subtype. Typically, antithrombotic therapy is initiated for cardioembolic stroke, while antiplatelet agents are used to prevent non-cardioembolic stroke, in addition to risk factor modification for all patients with stroke and TIA. The diagnosis of ischemic stroke subtype stems from a combination of patient history, clinical assessment, and cerebrovascular and cardiovascular evaluation. However, even with extensive testing, identifying the cause of cerebrovascular ischemia is challenging. This represents danger for the patient because when a definitive cause is not identified the stroke is defined as cryptogenic in origin and definitive prevention measures are unclear. Therefore, there is a great need to understand the pathogenesis of acute ischemic stroke in order to develop more effective preventative measures. Recent studies have suggested whole blood RNA expression may differentiate major ischemic stroke types.

References:

  1. Biomarkers of Acute Stroke Etiology (BASE) Study Methodology, Jauch, E.C., Barreto, A.D., Broderick, J.P. et al. Transl. Stroke Res. (2017) 8: 424. https://doi.org/10.1007/s12975-017-0537-3.

  2. Sharp, et al. Molecular markers and mechanisms of stroke: RNA studies of blood in animals and humans, Journal of Cerebral Blood Flow & Metabolism (2011) 31, 1513-1531; doi: 10.1038/jcbfm.2011.45:

  3. Dhamoon MS, Sciacca RR, Rundek T, Sacco RL, Elkind MS. Recurrent stroke and cardiac risks after first ischemic stroke: the Northern Manhattan Study. Neurology 2006:66:641-6.

  4. Kernan WN, Ovbiagele B, BLack HR, et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke; a journal of cerebral circulation 2014;45:2160-236.

  5. Jickling GC, Xu H, Stamova B, et al. Signatures of cardioembolic and large-vessel ischemic stroke. Ann Neurol 2010;68:681-92.

  6. Stamova B, Jickling GC, Ander BP, et al. Gene expression in peripheral immune cells following cardioembolic stroke is sexually dimorphic. PloS one 2014;9:e102550.

  7. Stamova B, Xu H, Jickling G, et al. Gene expression profiling of blood for the prediction of ischemic stroke. Stroke; a journal of cerebral circulation 2010;41:2171-

  8. Tian Y, Stamova B, Jickling GC, et al. Effects of gender on gene expression in the blood of ischemic stroke patients. Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism 2012;32:780-91.

  9. Jickling GC, Stamova B, Ander BP, et al. Prediciton of cardioembolic, arterial, and lacunar causes of cryptogenic stroke by gene expression and infarct location. Stroke; a journal of cerebral circulation 2012;43:2036-41.