N/A
N=82
Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke (VERiTAS)
Vertebrobasilar Insufficiency · Ischemic Attack, Transient · Cerebrovascular Disorder · Brain Ischemia · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00590980 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Fatal and Nonfatal Ischemic Stroke in the Vertebrobasilar Territory — 72 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatal and Nonfatal Ischemic Stroke in the Vertebrobasilar Territory |
72 | — |
Summary
Patients with blockage of the blood vessels that supply blood to the back of the brain, known as vertebrobasilar disease (VBD), are at risk of having a stroke or temporary symptoms of a stroke known as transient ischemic attack (TIA). The risk of repeated stroke associated with VBD may be affected by several risk factors, including the degree to which the blockage reduces the blood flow to the brain. Patients with VBD have different levels of blockage ranging from partial blockage to complete blockage, which can affect the blood flow to the brain by variable amounts. The purpose of this research is to determine if patients with symptomatic VBD who demonstrate low blood flow to the back of the brain on magnetic resonance (MR)imaging are at higher risk of developing another stroke or TIA than patients with normal blood flow.
Eligibility Criteria
Inclusion Criteria
- Stroke or TIA in the vertebrobasilar territory
- Conventional or CT angiographic demonstration of ≥50% stenosis or occlusion of extracranial or intracranial vertebrobasilar artery
- Symptoms within 60 days of enrollment
- Age 18 and above
- Able to provide informed consent
Exclusion Criteria
Neurologic criteria:
- Major disabling stroke prohibiting the ability to return for follow-up assessment
- Any neurological disease which would confound follow-up assessment
Medical criteria:
- Any severe co-morbidity condition with less than 12 month life expectancy
- Known cardiac disease associated with cardioembolic risk specifically atrial fibrillation, prosthetic valves, endocarditis, left atrial/ventricular thrombus, cardiomyopathy with EF<25%, cardiac myxoma
- Blood dyscrasias, specifically polycythemia vera, essential thrombocytosis, sickle cell disease
Disease criteria:
- Non-atherosclerotic disease vertebrobasilar disease including dissection, fibromuscular dysplasia, vasculitis, radiation induced vasculopathy
- Unilateral vertebral stenosis or occlusion
Patient criteria:
- Unable or unwilling to undergo MRI or cerebral angiography or CTA
- Pregnancy concurrent participation in an interventional trial for treatment of vertebrobasilar disease.
- Renal dysfunction will be exclusionary if it precludes angiography. No subjects will be excluded based upon gender, race, ethnic group, religion or socioeconomic status. Children will not be recruited as atherosclerotic VBD is a condition that affects adults primarily in later life and is not a disease that occurs or is relevant in children.
Data sourced from ClinicalTrials.gov (NCT00590980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.