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Biomarkers of Acute Stroke in Clinic

NCT03897478 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-09-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ischemia Care LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03897478 on ClinicalTrials.gov