Identifying stroke causes using blood tests
Biomarkers of Acute Stroke in Clinic
This study is testing a blood test to see if it can help doctors figure out the cause of different types of strokes in patients who have just had a stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ischemia Care LLC Industry-sponsored |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT03897478 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the clinical utility of the ISCDX blood test in differentiating between various types of acute ischemic strokes, specifically focusing on cardioembolic and large artery atherosclerotic strokes. The study will enroll patients who present with signs of acute ischemic stroke within 30 hours of symptom onset and will utilize gene expression analysis to identify stroke etiology. By establishing a clearer understanding of stroke causes, the study seeks to improve treatment strategies and secondary prevention measures for patients. The research will be conducted at multiple sites, with an estimated enrollment of up to 500 participants.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 who exhibit symptoms of acute ischemic stroke and arrive at the emergency department within 30 hours of symptom onset.
Not a fit: Patients with recent central nervous system infections, head trauma, or active cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and tailored treatments for patients suffering from acute ischemic strokes.
How similar studies have performed: Other studies have shown promise in using biomarker blood tests to differentiate stroke types, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Columbus, Ohio
- Ohio Health Riveside Methodist Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Judy Morgan, MBA, CCRC
- Email: judy@iscdx.com
- Phone: 513-827-9106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.