Biomarkers of Acute Stroke in Clinic
Launched by ISCHEMIA CARE LLC · Mar 29, 2019
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a test called ISCDX, which aims to help doctors understand the different causes of strokes. Strokes can happen for various reasons, and the trial focuses on two specific types: cardioembolic strokes, which are caused by blood clots that travel from the heart, and large artery atherosclerotic strokes, which occur due to blockages in the major arteries. The goal is to see if the ISCDX test can accurately tell the difference between these types of strokes, especially when the cause is not immediately clear.
To participate in this trial, individuals must be between the ages of 18 and 80 and show signs of an acute ischemic stroke (a type of stroke where blood flow to the brain is blocked). They should arrive at the emergency department within 30 hours of when their symptoms began. Participants will be required to provide informed consent and undergo some tests, including brain scans, to make sure they do not have other medical issues that could interfere with the study. This trial is currently looking for participants and aims to improve how doctors diagnose and treat strokes in the future.
Gender
ALL
Eligibility 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.
About Ischemia Care Llc
Ischemia Care LLC is a clinical trial sponsor dedicated to advancing medical research and innovation in the field of ischemic conditions. With a commitment to enhancing patient outcomes, the organization focuses on developing and testing novel therapeutic approaches through rigorous clinical studies. Ischemia Care LLC collaborates with healthcare professionals and research institutions to ensure the highest standards of ethical practice and scientific integrity in its trials. By prioritizing patient safety and data accuracy, Ischemia Care LLC aims to contribute valuable insights to the medical community and improve treatment options for individuals affected by ischemic diseases.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbus, Ohio, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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