Biomarkers of Acute Stroke in Clinic

NCT03897478 | Unknown DMC

• 1 other identifier: NCT02014896-2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ischemic stroke; Atrial fibrillation; Transient neurological event; Cryptogenic stroke; Gene expression; RNA; Anticoagulant; NOAC; Implantable cardiac monitor; Point of care; tPA; Thrombectomy; Cardiac monitoring

Outcome Measures

Primary Outcomes (1)

• Comparison of the rates of patients presenting with acute ischemic stroke identified with ISCDX testing with TOAST criteria

  The ISCDX test results will be compared to acute ischemic stroke assessment as defined by the TOAST criteria

  up to 1 year

Study Arms (2)

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

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

Interventions

ISCDX blood test DIAGNOSTIC_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.

Ischemic Stroke

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

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
• 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.

Sponsors & Collaborators

• Ischemia Care LLC: lead

Study Sites (1)

Ohio Health Riveside Methodist Hospital

Columbus, Ohio, 43214, United States

RECRUITING

Related Publications (1)

• Jauch EC, Barreto AD, Broderick JP, Char DM, Cucchiara BL, Devlin TG, Haddock AJ, Hicks WJ, Hiestand BC, Jickling GC, June J, Liebeskind DS, Lowenkopf TJ, Miller JB, O'Neill J, Schoonover TL, Sharp FR, Peacock WF. Biomarkers of Acute Stroke Etiology (BASE) Study Methodology. Transl Stroke Res. 2017 May 5;8(5):424-8. doi: 10.1007/s12975-017-0537-3. Online ahead of print.

  PMID: 28477280 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen will be whole blood samples.

MeSH Terms

Conditions

Ischemic Stroke; Ischemia; Atrial Fibrillation; Ischemic Attack, Transient; Thrombotic Stroke; Stroke; Atherosclerosis; Plaque, Atherosclerotic; Embolic Stroke; Cardiomyopathies; Myocardial Infarction; Thromboembolism

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Brain Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Myocardial Ischemia; Infarction; Necrosis; Embolism and Thrombosis

Central Study Contacts

Judy Morgan, MBA, CCRC

CONTACT

513-827-9106; judy@iscdx.com

Jeff June

CONTACT

513-827-9106; jeff.june@iscdx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 1, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)