Ischemia Care Biomarkers of Acute Stroke Etiology (BASE)



Status:Recruiting
Conditions:Atrial Fibrillation, Peripheral Vascular Disease, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:8/9/2018
Start Date:December 2013
End Date:December 2018
Contact:Jeffrey G June, CEO
Email:jeff.june@iscdx.com
Phone:513-827-9106

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The proposed study will validate the clinical use of new biomarker blood tests to identify
blood components that may differentiate between diverse stroke etiologies and clinical
outcomes as listed below:

1. Differentiate between cardioembolic and large artery atherosclerotic ischemic strokes,
when hemorrhagic stroke is ruled out.

2. In cases of ischemic strokes of unknown or "cryptogenic" etiology, determine the ability
of biomarker blood tests to predict etiology between cardioembolic and large artery
atherosclerotic.

3. In cases of cardioembolic ischemic stroke, further differentiation of cardioembolic
ischemic strokes into those caused by atrial fibrillation (AF) and those not caused by
AF.

4. Differentiate "transient ischemic attacks" (TIAs) from acute ischemic strokes.

5. Differentiate TIAs from non-ischemic "transient neurological events" (TNE) with similar
symptoms.

Acute ischemic stroke (AIS) is a leading cause of adult mortality and morbidity in the United
States, affecting over 800,000 individuals, annually, leaving many with permanent disability.
Furthermore, hundreds of thousands of Americans experience a transient ischemic attack (TIA),
a momentary episode of neurologic dysfunction, 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. Emergent evaluation, prompt acute
treatment, and identification of stroke etiology for secondary prevention are key to
decreasing the morbidity and mortality associated with cerebrovascular disease. Key to
treatment and prevention is the identification of stroke etiology - large vessel
atherosclerosis, cardioembolic phenomenon, or in-situ small vessel cerebrovascular disease -
since primary and secondary prevention measures differ based on stroke subtype. The diagnosis
of ischemic stroke includes a combination of patient history, clinical assessment, and brain
imaging. However, identifying the cause of cerebrovascular ischemia is challenging and
routinely assigned of cryptogenic origin.

Therefore, there is a great need to understand the pathogenesis of TIA and AIS events in
order to develop more effective preventative measures. Recent studies have identified the
differential expression of genes in whole blood that may differentiate the major ischemic
stroke types. Such differences may help identify TIA and AIS events that are more likely to
respond to therapy specifically tailored to the major stroke type. Furthermore, by
establishing a more robust standard for secondary prevention, future stroke events may be
avoided.

BASE is a multisite prospective study with a estimated enrollment of up to 1100 subjects
adult subjects and 100 age, gender and co-morbidity matched controls ("Controls") will be
recruited from patients who present to the Emergency Department (ED) or hospital with
suspected AIS or TIA. Research personnel will identify potential patients by responding to
"Brain Attacks" pages from the ED to the Stroke Team for patients who meet current Brain
Attack criteria. Following evaluation by the ED and neurology physicians, the clinical
coordinator will verify the patient had a suspected AIS or TIA and meets eligibility
criteria. The patient or their legal surrogate will be approached for study participation.
Written informed consent will be obtained for all subjects enrolled.

There are two recruitment windows related to BASE determined by time of symptom onset, time
of presentation at ED or hospital, and ability to consent:

1. "BASE" - patients that present with suspected stroke symptoms within 18 hours of symptom
onset or last known normal time OR

2. "BASE 24" - patients that present within 24 hours +/- 6 hours (i.e. 18 - 30 hour window)
of symptom onset or last known normal time and clinical evidence suggesting Acute
Ischemic Stroke.

Inclusion Criteria:

- Patients >18 years of age

- Signs and symptoms suggestive of AIS or TIA

- One of the following:

1. BASE - Arrival to the emergency department or hospital within 18 hrs of symptom
onset or last known normal time

2. BASE 24 - Arrival to the emergency department or hospital within 24 hours +/- 6
hours (i.e. 18 - 30 hour window) of symptom onset or last known normal time and
clinical evidence suggesting Acute Ischemic Stroke.

- Head CT or MRI ruling out other pathology such as vascular malformation, hemorrhage,
tumor or abscess which would likely be responsible for presenting neurologic symptoms

- Informed consent obtained

Exclusion Criteria:

- Any central nervous system infection, i.e. meningitis or encephalitis in the past 30
days

- Any form of head trauma, stroke or intracranial hemorrhage in the past 30 days

- Known primary or metastatic cancer involving the brain

- Active Cancer defined as a diagnosis of cancer, within 6 months before enrollment, any
treatment for cancer within the previous 6 months, or recurrent or metastatic cancer.

- Autoimmune diseases: such as lupus, rheumatoid arthritis, Crohn's disease, ulcerative
colitis

- Active infectious diseases (eg. HIV/AIDS, hepatitis C)

- Any underlying medical condition which in the opinion of the investigator would
prohibit the patient from providing informed consent

- Major surgery within three months prior to the index event
We found this trial at
22
sites
Philadelphia, Pennsylvania
Principal Investigator: Brett Cucchiara, MD
Phone: 215-662-7673
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Alison Haddock, MD
Phone: 713-873-7042
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Bronx, New York 10467
Principal Investigator: Mellanie Springer, MD
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Chapel Hill, North Carolina 27599
Principal Investigator: David Y Huang, MD, PhD
Phone: 919-962-5137
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Edward Jauch, MD MS
Phone: 843-792-4093
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chattanooga, Tennessee 37403
Principal Investigator: Thomas Devlin, MD PhD
Phone: 423-648-0304
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Columbus, Ohio 43214
Principal Investigator: William J Hicks, MD
Phone: 614-566-1255
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Columbus, OH
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Joseph Miller, MD
Phone: 313-916-9551
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Alexander T. Limkakeng Jr., MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Houston, Texas 77030
Phone: 713-500-7084
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Principal Investigator: Timothy Schoonover, DO FACN
Phone: 937-395-8483
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Livingston, New Jersey 07039
Principal Investigator: Danielle Haskins, MD
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: John O'Neill, MD
Phone: 412-359-8763
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Portland, Oregon 97213
Principal Investigator: Ted Lowenkopf, MD
Phone: 503-216-2736
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Royal Oak, Michigan 48073
Principal Investigator: Carol Clark, MD
Phone: 248-898-1792
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Sacramento, California 95816
Principal Investigator: Lucian Maiden, MD
Phone: 916-733-6253
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Saint Louis, Missouri 63110
Principal Investigator: Douglas Char, MD
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San Francisco, California 94110
Principal Investigator: Debbie Madhok, MD
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San Francisco, California 94143
Principal Investigator: Debbie Madhok, MD
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Winston-Salem, North Carolina 27157
Principal Investigator: Brian Hiestand, MD
Phone: 336-716-2059
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800 Forest Ave.
Zanesville, Ohio 43701
(740) 454-5000
Principal Investigator: James Neuenschwander, MD
Genesis Healthcare System Genesis HealthCare System is an integrated health care delivery system based in...
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