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Ischemic StrokeBASENCT02014896

Ischemia Care Biomarkers of Acute Stroke Etiology (BASE)

An observational study of Ischemic Stroke and Atrial Fibrillation, run by Ischemia Care LLC at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biomarker blood draw
How many people
1,750 participants
Where
22 sitesUnited States
Study dates
Dec 2013to Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects eligible for enrollment include: 1. Ischemic stroke within 24 hours of symptom onset. 2. Transient Ischemic Attack (TIA) within 24 hours of symptom onset. 3. Non-ischemic transient neurologic event (TNE) within 24 hours of onset. 4. Normal controls that will be non-neurologic patients who are matched with the other ischemic stroke and TIA patients for age, race, gender and smoking plus one or more of the following vascular risk factors: diabetes, hypertension, atrial fibrillation, hyperlipidemia.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • University of North Carolina Department of Neurology - Stroke Division

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Chattanooga Center for Neurologic Research

    Chattanooga, Tennessee, 37403

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Riverside Methodist Hospital/ Ohio Health Research Institute

    Columbus, Ohio, 43214

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Baylor College of Medicine

    Houston, Texas, 77030

  • UT Health Department of Neurology

    Houston, Texas, 77030

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • The Stroke Center at Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Providence Health and Services

    Portland, Oregon, 97225

  • William Beaumont Hospital - Beaumont Health System

    Royal Oak, Michigan, 48073

  • Dignity Health Mercury San Juan

    Sacramento, California, 95816

  • Zuckerberg San Francisco General Hospital (UCSF)

    San Francisco, California, 94110

  • University of California San Francisco Medical Center Hospital

    San Francisco, California, 94143

  • Washington University, University Hospital in St Louis

    St Louis, Missouri, 63110

  • Montefiore Medical Center (University Hospital for Albert Einstein College of Medicine)

    The Bronx, New York, 10467

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27157

  • Genesis Healthcare System

    Zanesville, Ohio, 43701

Other trials in United States

About this study

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.
Read the detailed description

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.
Being tested
Biomarker blood draw
Keywords
Ischemic Stroke, Transient Ischemic Attack, Transient Neurological Event, Atrial Fibrillation, Cryptogenic Stroke, Gene Expression, RNA, Anticoagulant, NOAC, Antiplatelet, Cardiac monitoring, Point of Care, tPA, Atheroembolic
Medical subject headings
Ischemic Stroke, Atrial Fibrillation, Ischemic Attack, Transient, Thrombotic Stroke, Embolic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biomarker blood drawOther

    Also called PAX Gene Blood RNA tube, PreAnalytiX, Germnay

    Comparison of gene expression profiles using RNA isolated from whole blood.

Study groups in NCT02014896
Study groupRoleWhat they receive
Ischemic StrokeIschemic stroke subjects presenting within 24 hours from symptom onset will have serial PAX Gene Blood RNA tubes drawn within 18 hours of onset of symptoms upon arrival to the Emergency Department (if available) or hospital; 24 hours +/- 6 hours from symptom onset (if available) and 48 hours+/- 6 hours from symptom onset (if available). Biomarker blood draw
Receives: Other: Biomarker blood draw
TIA (Transient Ischemic Attack)TIA subjects presenting within 24 hours from symptom onset will have serial PAX Gene Blood RNA tubes drawn within 18 hours of onset of symptoms upon arrival to the Emergency Department (if available) or hospital; 24 hours +/- 6 hours from symptom onset (if available) and 48 hours+/- 6 hours from symptom onset (if available). Biomarker blood draw
Receives: Other: Biomarker blood draw
Non-Ischemic TNENon-Ischemic Transient Neurological Event (TNE) subjects will have serial PAX Gene Blood RNA tubes drawn within 18 hours of onset of symptoms upon arrival to the Emergency Department or hospital. Biomarker blood draw
Receives: Other: Biomarker blood draw
ControlControl group subjects will have PAX Gene Blood RNA tubes drawn within 8 hours of arrival to the Emergency Department or hospital. Control group matched with ischemic stroke and TIA subjects for age, race, gender, smoking history with at least one of the following vascular risk factors: diabetes, hypertension, atrial fibrillation, hyperlipidemia. Biomarker blood draw
Receives: Other: Biomarker blood draw

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardioembolic and large vessel stroke stiology

    Determine the ability of ISCDX, a blood test, to differentiate between clinically diagnosed cardioembolic and large artery atherosclerotic ischemic stroke when hemorrhagic stroke is ruled out.

    Measured: Up to 60 days.

  2. TIA differentiation from non ischemic events (TNE).

    Determine the ability of TIADX, a blood test, to identify clinically diagnosed TIAs and differentiate these events from controls, which include TNEs. TNEs represent patients presenting with clinical symptoms similar to a TIA such as migraines, seizures and syncope, which are non-ischemic transient neurological events (TNE).

    Measured: Up to 60 days.

Secondary outcomes (3)

  1. Cryptogenic stroke

    Determine the ability of ISCDX to categorize strokes of cryptogenic strokes, as either cardioembolic or large artery atherosclerotic when best practice clinical diagnostic testing cannot determine the cause, suggesting the best treatment pathway.

    Measured: Up to 60 days.

  2. Atrial fibrillation and stroke

    Determine the ability of ISCDX to further sub-classify strokes diagnosed as cardioembolic into those caused by atrial fibrillation and those not caused by atrial fibrillation, such as structural defects in the heart.

    Measured: Up to 60 days.

  3. Stroke and TIA, differentiation

    Determine the ability of the ISCDX and TIADX tests to differentiate between a TIA and an ischemic stroke, much in the manner that Acute Coronary Syndrome is now viewed as part of a spectrum of cardiovascular diseases.

    Measured: Up to 60 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionNov 2019
  4. Study completionJan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,750 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02014896
Sponsor's protocol ID
ISCH01
Acronym
BASE
Status last verified
Jul 2020
First submitted
5 Dec 2013
Last updated
8 Jul 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35.

    PubMed 7678184

  • Ovbiagele B, Saver JL, Fredieu A, Suzuki S, Selco S, Rajajee V, McNair N, Razinia T, Kidwell CS. In-hospital initiation of secondary stroke prevention therapies yields high rates of adherence at follow-up. Stroke. 2004 Dec;35(12):2879-83. doi: 10.1161/01.STR.0000147967.49567.d6. Epub 2004 Oct 28.

    PubMed 15514170

  • Ionita CC, Xavier AR, Kirmani JF, Dash S, Divani AA, Qureshi AI. What proportion of stroke is not explained by classic risk factors? Prev Cardiol. 2005 Winter;8(1):41-6. doi: 10.1111/j.1520-037x.2005.3143.x.

    PubMed 15722693

  • Stead LG, Gilmore RM, Bellolio MF, Jain A, Rabinstein AA, Decker WW, Agarwal D, Brown RD Jr. Cardioembolic but not other stroke subtypes predict mortality independent of stroke severity at presentation. Stroke Res Treat. 2011;2011:281496. doi: 10.4061/2011/281496. Epub 2011 Oct 10.

    PubMed 22007347

  • Kamel et al. J Stroke Cerebrolvasc Dis; 2009 Nov-Dec;18(6):453-7. The risk of stroke recurrence is four times greater among prior stroke patients with newly detected AF.

  • Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8. doi: 10.1161/01.str.22.8.983.

    PubMed 1866765

  • Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.

    PubMed 17577005

  • Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC, Halperin JL, Johnston SC, Katzan I, Kernan WN, Mitchell PH, Ovbiagele B, Palesch YY, Sacco RL, Schwamm LH, Wassertheil-Smoller S, Turan TN, Wentworth D; American Heart Association Stroke Council, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Interdisciplinary Council on Quality of Care and Outcomes Research. Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the american heart association/american stroke association. Stroke. 2011 Jan;42(1):227-76. doi: 10.1161/STR.0b013e3181f7d043. Epub 2010 Oct 21.

    PubMed 20966421

  • Jickling GC, Xu H, Stamova B, Ander BP, Zhan X, Tian Y, Liu D, Turner RJ, Mesias M, Verro P, Khoury J, Jauch EC, Pancioli A, Broderick JP, Sharp FR. Signatures of cardioembolic and large-vessel ischemic stroke. Ann Neurol. 2010 Nov;68(5):681-92. doi: 10.1002/ana.22187.

    PubMed 21031583

  • Jickling GC, Zhan X, Stamova B, Ander BP, Tian Y, Liu D, Sison SM, Verro P, Johnston SC, Sharp FR. Ischemic transient neurological events identified by immune response to cerebral ischemia. Stroke. 2012 Apr;43(4):1006-12. doi: 10.1161/STROKEAHA.111.638577. Epub 2012 Feb 2.

    PubMed 22308247

  • Tang Y, Lu A, Aronow BJ, Sharp FR. Blood genomic responses differ after stroke, seizures, hypoglycemia, and hypoxia: blood genomic fingerprints of disease. Ann Neurol. 2001 Dec;50(6):699-707. doi: 10.1002/ana.10042.

    PubMed 11761467

  • Tang Y, Xu H, Du X, Lit L, Walker W, Lu A, Ran R, Gregg JP, Reilly M, Pancioli A, Khoury JC, Sauerbeck LR, Carrozzella JA, Spilker J, Clark J, Wagner KR, Jauch EC, Chang DJ, Verro P, Broderick JP, Sharp FR. Gene expression in blood changes rapidly in neutrophils and monocytes after ischemic stroke in humans: a microarray study. J Cereb Blood Flow Metab. 2006 Aug;26(8):1089-102. doi: 10.1038/sj.jcbfm.9600264. Epub 2006 Jan 4.

    PubMed 16395289

  • Xu H, Tang Y, Liu DZ, Ran R, Ander BP, Apperson M, Liu XS, Khoury JC, Gregg JP, Pancioli A, Jauch EC, Wagner KR, Verro P, Broderick JP, Sharp FR. Gene expression in peripheral blood differs after cardioembolic compared with large-vessel atherosclerotic stroke: biomarkers for the etiology of ischemic stroke. J Cereb Blood Flow Metab. 2008 Jul;28(7):1320-8. doi: 10.1038/jcbfm.2008.22. Epub 2008 Apr 2.

    PubMed 18382470

  • Stamova B, Xu H, Jickling G, Bushnell C, Tian Y, Ander BP, Zhan X, Liu D, Turner R, Adamczyk P, Khoury JC, Pancioli A, Jauch E, Broderick JP, Sharp FR. Gene expression profiling of blood for the prediction of ischemic stroke. Stroke. 2010 Oct;41(10):2171-7. doi: 10.1161/STROKEAHA.110.588335. Epub 2010 Aug 26.

    PubMed 20798371

  • Jickling GC, Stamova B, Ander BP, Zhan X, Tian Y, Liu D, Xu H, Johnston SC, Verro P, Sharp FR. Profiles of lacunar and nonlacunar stroke. Ann Neurol. 2011 Sep;70(3):477-85. doi: 10.1002/ana.22497. Epub 2011 Jul 27.

    PubMed 21796664

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke and Atrial Fibrillation, run by Ischemia Care LLC at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardioembolic and large vessel stroke stiology (time frame: Up to 60 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02014896, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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