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Biomarkers of Acute Stroke in Clinic (BASIC)

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ClinicalTrials.gov Identifier: NCT03897478
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ischemia Care LLC

Brief Summary:

The proposed study will investigate the clinical use of the ISCDX test that may differentiate between diverse stroke etiologies as listed below:

Aim 1: Differentiate between cardioembolic and large artery atherosclerotic ischemic strokes, when hemorrhagic stroke is ruled out, as defined by TOAST classification of subtypes of acute ischemic stroke.

Aim 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.


Condition or disease Intervention/treatment
Ischemic Stroke Ischemia Atrial Fibrillation Transient Ischemic Attack Transient Cerebrovascular Events Thrombotic Stroke Stroke Stroke, Acute Stroke, Ischemic Stroke, Complication Stroke of Basilar Artery Atherosclerosis Atheroma Cardioembolic Stroke Cardiomyopathies Cardiovascular Stroke Thromboembolism Diagnostic Test: ISCDX blood test

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. 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, the need is great, to understand the pathogenesis of AIS events in order to develop more effective preventative measures. Recent studies have identified the differential expression of genes in whole blood which may differentiate the major ischemic stroke types. Such differences may help identify 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.

BASIC is a multisite prospective study with a estimated enrollment of up to 500 consecutive adult subjects including no more than 50 age, gender and co-morbidity matched controls ("Controls"). Stroke subjects will be recruited from patients who present to the Emergency Department (ED) or hospital with suspected AIS. Research personnel will identify potential patients by responding to "Brain Attack" 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 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.

Control subjects will be those who present to the Emergency Department for non-stroke reasons but have one or more risk factors for stroke. These subjects will not have a recruitment window. They can be consented as they present to the hospital. Tubes will be marked as controls. In past studies, these have been collected during slow times in the Emergency Department. Once the study has reached 50 controls, the sponsor will stop enrolling for this group. This has been done in the past by sending the sites a communication that the control group quota has been reached.

The recruitment window will be determined by time of symptom onset, time of presentation at ED or hospital, and ability to consent. This will include patients that present within 30 hours of symptom onset or last known normal time and clinical evidence suggesting Acute Ischemic Stroke.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of Acute Stroke in Clinic
Estimated Study Start Date : August 31, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Ischemic Stroke

Ischemic stroke subjects presenting within 30 hours from symptom onset will have al PAX Gene Blood RNA tubes drawn upon arrival to the Emergency Department (if available) or hospital.

Biomarker blood draw

Diagnostic Test: ISCDX blood test

The ISCDX test is based on gene expression changes that occur as a result of the ischemic stroke. When the stroke occurs, the immune system in the body reacts and causes changes in gene expression in several types of cells, including white blood cells, related to activation of innate and adaptive immune systems.

The ISCDX test distinguishes between cardioembolic and large artery atherosclerotic origin of stroke using a gene signature. The pattern or signature of up or down regulation for all genes for a patient determines whether the patient's pattern of gene expression is more like the pattern seen in other cardioembolic patients or more like the pattern seen in patients with large artery atherosclerotic cause of stroke.


Control

Control group subjects will have PAX Gene Blood RNA tubes drawn. Control group matched with ischemic stroke 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




Primary Outcome Measures :
  1. Comparison of the rates of patients presenting with acute ischemic stroke identified with ISCDX testing with TOAST criteria [ Time Frame: up to 1 year ]
    The ISCDX test results will be compared to acute ischemic stroke assessment as defined by the TOAST criteria


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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Source of Subject Population:

Ischemic stroke population will be adult patients who present to the Emergency Department or hospital with an acute ischemic strokeor meet the definition of a control subject who meet the inclusion/exclusion criteria.

Controls subjects will be non-neurologic patients who are matched with the stroke patients for age, race, gender and smoking plus one or more of the following co-morbidities or vascular risk factors:

  1. Diabetes
  2. Hypertension
  3. Atrial fibrillation
  4. Hyperlipidemia
Criteria

Inclusion Criteria:

  • Patients >18 and < 80 years of age.
  • Signs and symptoms suggestive of AIS due to cardioembolic, large vessel, or unknown etiology according to TOAST criteria.
  • Arrival to the ED within 30 hours 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
  • Any history of primary or metastatic brain cancer
  • 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 chronic 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
  • Signs and symptoms suggestive of (i) AIS due to small vessel occlusion (lacune) and other known etiology according to TOAST criteria, as well as (ii) stroke mimics, transient ischemic attacks, or transient neurological events.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897478


Contacts
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Contact: Judy Morgan, MBA, CCRC 513-827-9106 judy@iscdx.com
Contact: Jeff June 513-827-9106 jeff.june@iscdx.com

Sponsors and Collaborators
Ischemia Care LLC

Publications:
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Responsible Party: Ischemia Care LLC
ClinicalTrials.gov Identifier: NCT03897478     History of Changes
Other Study ID Numbers: NCT02014896-2
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ischemia Care LLC:
Ischemic stroke
Atrial fibrillation
Transient neurological event
Cryptogenic stroke
Gene expression
RNA
Anticoagulant
NOAC
Implantable cardiac monitor
Point of care
tPA
Thrombectomy
Cardiac monitoring
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Atrial Fibrillation
Atherosclerosis
Cardiomyopathies
Thromboembolism
Myocardial Infarction
Ischemia
Plaque, Atherosclerotic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Embolism and Thrombosis
Brain Ischemia
Pathological Conditions, Anatomical
Myocardial Ischemia