Ischemia Care Biomarkers of Acute Stroke Etiology (BASE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Ischemia Care LLC
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Ischemia Care LLC
ClinicalTrials.gov Identifier:
NCT02014896
First received: December 5, 2013
Last updated: January 2, 2014
Last verified: January 2014
  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
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: 350
Study Start Date: December 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ischemic Stroke

Ischemic stroke subjects will have 2 PAX Gene Blood RNA tubes drawn at 8 hours of onset of symptoms upon arrival to the Emergency Department or hospital; 24 hours +/- 6 hours from symptom onset and 48 hours+/- 6 hours from symptom onset or discharge from the hospital, whichever comes first.

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 will have 2 PAX Gene Blood RNA tubes drawn at 8 hours of onset of symptoms upon arrival to the Emergency Department or hospital; 24 hours +/- 6 hours from symptom onset and 48 hours+/- 6 hours from symptom onset or discharge from the hospital whichever comes first.

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 2 PAX Gene Blood RNA tubes drawn at 8 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 2 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects eligible for enrollment include:

  1. Ischemic stroke within 8 hours of symptom onset.
  2. Transient Ischemic Attack (TIA) within 8 hours of symptom onset.
  3. Non-ischemic transient neurologic event (TNE) within 8 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 acute ischemic stroke or TIA Arrival to the emergency department or hospital within 8 hrs of symptom onset or last known normal time
  • 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
  • Consent must be 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, BS 513-827-9106 jeff.june@iscdx.com
Contact: Penelope Isabella, PhD 513-827-9106 penny@iscdx.com

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sharon A O'Keefe, RN/BSN    216-445-4594    okeefes@ccf.org   
Contact: Tracy M Barbour    216-444-0231    barbout@ccf.org   
Principal Investigator: Sharon E Mace, M.D.         
Sponsors and Collaborators
Ischemia Care LLC
The Cleveland Clinic
Investigators
Principal Investigator: Sharon E Mace, MD The Cleveland Clinic
  More Information

Publications:
Furie KL, Kasner SE, Adams RJ, et al . 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;42:227-76

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: January 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ischemia Care LLC:
Ischemic Stroke
Transient Ischemic Attack
Transient Neurological Event
Atrial Fibrillation
Cryptogenic Stroke
Gene Expression
RNA

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

ClinicalTrials.gov processed this record on July 22, 2014