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Ischemia Care Biomarkers of Acute Stroke Etiology (BASE) (BASE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Ischemia Care LLC
Sponsor:
Information provided by (Responsible Party):
Ischemia Care LLC
ClinicalTrials.gov Identifier:
NCT02014896
First received: December 5, 2013
Last updated: August 29, 2016
Last verified: August 2016
  Purpose

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.

Condition Intervention
Ischemic Stroke
Atrial Fibrillation
Transient Ischemic Attacks
Transient Cerebrovascular Events
Thrombotic Stroke
Stroke of Basilar Artery
Cardioembolic Stroke
Other: Biomarker blood draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ischemia Care Biomarkers of Acute Stroke Etiology (BASE)

Resource links provided by NLM:


Further study details as provided by Ischemia Care LLC:

Primary Outcome Measures:
  • RNA gene expression in peripheral blood. [ Time Frame: Up to 60 days. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Biospecimen will be whole blood samples.

Estimated Enrollment: 1400
Study Start Date: December 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ischemic Stroke

Ischemic 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

Other: Biomarker blood draw
Comparison of gene expression profiles using RNA isolated from whole blood.
Other Name: PAX Gene Blood RNA tube, PreAnalytiX, Germnay
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

Other: Biomarker blood draw
Comparison of gene expression profiles using RNA isolated from whole blood.
Other Name: PAX Gene Blood RNA tube, PreAnalytiX, Germnay
Non-Ischemic TNE

Non-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

Other: Biomarker blood draw
Comparison of gene expression profiles using RNA isolated from whole blood.
Other Name: PAX Gene Blood RNA tube, PreAnalytiX, Germnay
Control

Control 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

Other: Biomarker blood draw
Comparison of gene expression profiles using RNA isolated from whole blood.
Other Name: PAX Gene Blood RNA tube, PreAnalytiX, Germnay

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014896

Contacts
Contact: Jeffrey G June, CEO 513-827-9106 jeff.june@iscdx.com
Contact: Judy Morgn, CCRC 513-827-9106 Judy@iscdx.com

Locations
United States, California
Dignity Health Mercury San Juan Recruiting
Sacramento, California, United States, 95816
Contact: Lindsey Holloway    916-733-6253      
Principal Investigator: Lucian Maiden, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Shannen Berry    313-916-9551    sberry9@hfhs.org   
Principal Investigator: Joseph Miller, MD         
William Beaumont Hospital - Beaumont Health System Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Mara Branoff    248-898-1792      
Principal Investigator: Carol Clark, MD         
United States, New Jersey
The Stroke Center at Saint Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Kelly E Roe, RN       KRoe@barnabashealth.org   
Principal Investigator: Danielle Haskins, MD         
United States, New York
Montefiore Medical Center (University Hospital for Albert Einstein College of Medicine) Recruiting
Bronx, New York, United States, 10467
Principal Investigator: Mellanie Springer, MD         
United States, North Carolina
University of North Carolina Department of Neurology - Stroke Division Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Laura Pinto-Coelho, BA    919-962-5137    pinto@neurology.unc.edu   
Principal Investigator: David Y Huang, MD, PhD         
Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Erin Harper, MSHS, CCRP    336-716-2059      
Principal Investigator: Brian Hiestand, MD         
United States, Ohio
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital/ Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Mindie Taylor, RN CCRC    614-566-1255    Mindie.Taylor@ohiohealth.com   
Contact: Laura Reebel, RN         
Principal Investigator: William J Hicks, MD         
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Contact: Tammy Schleich, RT    937-395-8483    Tammy.Schleich@khnetwork.org   
Principal Investigator: Timothy Schoonover, DO FACN         
Genesis Healthcare System Recruiting
Zanesville, Ohio, United States, 43701
Principal Investigator: James Neuenschwander, MD         
United States, Oregon
Providence Health and Services Recruiting
Portland, Oregon, United States, 97225
Contact: Arlena Georgeson, CCRP    503-216-2736    arlena.georgeson@providence.org   
Principal Investigator: Ted Lowenkopf, MD         
United States, Pennsylvania
University of Pennsylvania Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Melissa Kruszewski    215-662-7673    Melissa.Kruszewski@uphs.upenn.edu   
Principal Investigator: Brett Cucchiara, MD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Kelly Szabo, BS MPH    412-359-8763    kszabo1@wpahs.org   
Principal Investigator: John O'Neill, MD         
Sub-Investigator: Arvind Venkat, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Dreema Murray    843-792-4093    murrayd@musc.edu   
Contact: Robert Burfeind, CCRP         
Principal Investigator: Edward Jauch, MD MS         
United States, Tennessee
Chattanooga Center for Neurologic Research Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Katrina Barton, CCRC    423-648-0304      
Contact: Ticey Massengale         
Principal Investigator: Thomas Devlin, MD PhD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Kelly Rogers Keene, BSN, RN    713-873-7042    kelly.keene@bcm.edu   
Principal Investigator: Alison Haddock, MD         
UT Health Department of Neurology Recruiting
Houston, Texas, United States, 77030
Contact: Loren Shen, RN BSN    713-500-7084      
Contact: Andrew D Barreto, MD MS         
Sponsors and Collaborators
Ischemia Care LLC
Investigators
Principal Investigator: Frank Peacock, MD Ischemia Care
Principal Investigator: Edward Jauch, MD Medical University of South Carolina
  More Information

Publications:
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.

Responsible Party: Ischemia Care LLC
ClinicalTrials.gov Identifier: NCT02014896     History of Changes
Other Study ID Numbers: ISCH01 
Study First Received: December 5, 2013
Last Updated: August 29, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Ischemia Care LLC:
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

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Ischemia
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Brain Ischemia

ClinicalTrials.gov processed this record on September 27, 2016