Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke (VERiTAS)
Ischemic Attack, Transient
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke (VERiTAS) Study|
- Fatal and nonfatal ischemic stroke in the vertebrobasilar territory [ Time Frame: one year ] [ Designated as safety issue: No ]
- Ischemic stroke in any vascular territory [ Time Frame: one to two years ] [ Designated as safety issue: No ]
- All ischemic stroke and vascular death [ Time Frame: one to two years ] [ Designated as safety issue: No ]
- Aggregate of any ischemic stroke, myocardial infarction and vascular death [ Time Frame: one to two years ] [ Designated as safety issue: No ]
- All stroke (ischemic and hemorrhagic) [ Time Frame: one to two years ] [ Designated as safety issue: No ]
- All death (vascular and nonvascular) [ Time Frame: one to two years ] [ Designated as safety issue: No ]
- Neurological impairment as determined by the NIH Stroke Scale [ Time Frame: one to two years ] [ Designated as safety issue: No ]
- Neurological disability as determined by the modified Barthel Index [ Time Frame: one to two years ] [ Designated as safety issue: No ]
- Handicap as determined by the modified Rankin Scale [ Time Frame: one to two years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||December 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.
Approximately 700,000 strokes occur annually in the U.S. making it the third leading cause of death and the leading cause of permanent disability among adults. Over one third of strokes occur in the posterior circulation, the leading cause of which is vertebrobasilar occlusive disease secondary to atherosclerosis. Symptomatic vertebrobasilar disease (VBD) carries a high annual risk of stroke, averaging 10-15% per year despite medical therapy. This represents a potentially treatable high risk stroke etiology. Advances in endovascular angioplasty and stenting have created new treatment options, but these interventions carry significant risks, and the selection criteria for appropriate candidates remains uncertain. Determining predictors of stroke in this population is the first step toward identifying those high risk patients most suitable for consideration of intervention. Our preliminary studies suggest that the risk of stroke in VBD is strongly related to the extent to which intracranial blood flow is compromised.
The objective is to conduct a longitudinal study of patients with symptomatic VBD. Our central hypothesis is that patients with symptomatic VBD who demonstrate limitation of blood flow on quantitative magnetic resonance angiography (QMRA) are at higher risk of stroke.The primary aim of this proposal is to test the hypothesis that among patients with VBD, those with distal blood flow compromise are at higher risk of subsequent posterior circulation stroke than those with normal flow.
Secondary exploratory aims of the proposal are to determine:the correlation between large vessel flow measured by QMRA and tissue level perfusion measured by MR perfusion in the posterior circulation, and the predictive value of each; other predictive factors for stroke in this population; hemodynamic effects of varying degrees of vertebrobasilar stenosis; changes in hemodynamic status of patients on medical therapy over time; utility of QMRA as a non-invasive screening and monitoring tool in VBD.
The study consist of a prospective multi-center observational cohort study of patients with symptomatic angiographically confirmed vertebrobasilar atherostenosis (≥ 50%), or occlusion). Upon enrollment, patients will undergo hemodynamic assessment with noninvasive MR imaging (including QMRA and MR perfusion), the results of which will be kept blinded from treating physicians and the patients. Patients will be prospectively designated as demonstrating compromised or normal distal cerebral flow based upon an existing validated algorithm of individual posterior circulation vessel flow measurements. Baseline demographic, clinical and laboratory data will be gathered. Subsequently, patients will have monthly clinical follow-up and be re-imaged with QMRA at 6 month intervals for a minimum of 12 months. The primary endpoint will be stroke incidence in the vertebrobasilar territory at one year. Survival analysis methods, with censoring of patients not achieving endpoint at the end of the study period, will be used for comparison of patients with compromised versus normal blood flow.
The overall goal of the study is to define the population of patients with symptomatic VBD at highest risk of recurrent ischemic events. The information gained can significantly impact the selection criteria and likelihood for success of future clinical trials aimed at assessing the efficacy of endovascular or surgical interventions for the treatment of VBD. Moreover, the ability to define a low risk population in whom the risks of expensive invasive interventions would be unnecessary will have an equally important impact on the management of the disease both from a clinical and cost perspective. Data regarding the hemodynamic effects and changes over time of vertebrobasilar occlusive disease may also enhance our understanding of the basic pathophysiology and mechanisms of stroke in this morbid disease entity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590980
|United States, California|
|University of California at Los Angeles - UCLA|
|Los Angeles, California, United States, 90095|
|United States, Illinois|
|Jeffrey Kramer, MDSC at Mercy Hospital|
|Chicago, Illinois, United States, 60616|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|United States, New York|
|New York, New York, United States, 10032|
|UHN-Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|Principal Investigator:||Sepideh Amin-Hanjani, MD||University of Illinois, Department of Neurosurgery|