Ischemia Care Biomarkers of Acute Stroke Etiology (BASE)

Completed

Conditions studied: Ischemic Stroke, Atrial Fibrillation, Transient Ischemic Attacks, Transient Cerebrovascular Events, Thrombotic Stroke, Stroke of Basilar Artery, Cardioembolic Stroke

In brief

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.

Key facts

Study ID

NCT02014896

Run by

Ischemia Care LLC

People needed

1750

Starts

2013-12-01

Expected to finish

2020-01-01

Last updated by the study team

2020-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients >18 years of age
• Signs and symptoms suggestive of AIS or TIA
• One of the following:
• BASE - Arrival to the emergency department or hospital within 18 hrs of symptom onset or last known normal time
• 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

You may not qualify if…

• 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

Where it is running

• Dignity Health Mercury San Juan — Sacramento, California, United States
• Zuckerberg San Francisco General Hospital (UCSF) — San Francisco, California, United States
• University of California San Francisco Medical Center Hospital — San Francisco, California, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• William Beaumont Hospital - Beaumont Health System — Royal Oak, Michigan, United States
• Washington University, University Hospital in St Louis — St Louis, Missouri, United States
• The Stroke Center at Saint Barnabas Medical Center — Livingston, New Jersey, United States
• Montefiore Medical Center (University Hospital for Albert Einstein College of Medicine) — The Bronx, New York, United States
• University of North Carolina Department of Neurology - Stroke Division — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Riverside Methodist Hospital/ Ohio Health Research Institute — Columbus, Ohio, United States
• Kettering Medical Center — Kettering, Ohio, United States
• Genesis Healthcare System — Zanesville, Ohio, United States
• Providence Health and Services — Portland, Oregon, United States
• University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Chattanooga Center for Neurologic Research — Chattanooga, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• UT Health Department of Neurology — Houston, Texas, United States

Full record on ClinicalTrials.gov

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