Recruiting

Observational Study

Sponsor:

Ischemia Care LLC

Code:

NCT03897478

Conditions

Ischemic Stroke

Ischemia

Atrial Fibrillation

Transient Ischemic Attack

Transient Cerebrovascular Events

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ISCDX blood test

Study Details

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

Study ID

NCT03897478

Start date

Apr 1, 2019

Status verified date

Sep, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

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.

Primary outcome measure

  • Comparison of the rates of patients presenting with acute ischemic stroke identified with ISCDX testing with TOAST criteria [ Time Frame: up to 1 year ]

Central Contacts and Locations

Central contacts

Judy Morgan, MBA, CCRC

513-827-9106judy@iscdx.com

Jeff June

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

Locations

Ohio Health Riveside Methodist Hospital

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Jennifer Czerniak, RN

614-566-1254

Principal Investigator:

William J Hicks, MD

More Information

Sponsor

Ischemia Care LLC

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ischemia Care LLC on 2023-09-28.