Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke (VERiTAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sepideh Amin-Hanjani, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00590980
First received: December 28, 2007
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


Condition
Vertebrobasilar Insufficiency
Ischemic Attack, Transient
Cerebrovascular Disorder
Brain Ischemia
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke (VERiTAS) Study

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Fatal and nonfatal ischemic stroke in the vertebrobasilar territory [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: July 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Neurology/Neurosurgery Clinic

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00590980

Locations
United States, California
University of California at Los Angeles - UCLA
Los Angeles, California, United States, 90095
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Jeffrey Kramer, MDSC at Mercy Hospital
Chicago, Illinois, United States, 60616
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
Columbia University
New York, New York, United States, 10032
Canada, Ontario
UHN-Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
Sepideh Amin-Hanjani
Investigators
Principal Investigator: Sepideh Amin-Hanjani, MD University of Illinois, Department of Neurosurgery
  More Information

Additional Information:
Publications:
Responsible Party: Sepideh Amin-Hanjani, Professor, Department of Neurosurgery, University of Illinois at Chicago, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00590980     History of Changes
Other Study ID Numbers: 2006-0599, 5R01NS059745
Study First Received: December 28, 2007
Last Updated: August 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
Stroke
TIA (transient ischemic attack)
Brain
Blood Flow
Quantitative magnetic resonance angiography (QMRA)

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Ischemia
Vertebrobasilar Insufficiency
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction

ClinicalTrials.gov processed this record on September 16, 2014