NCT00590980

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3 years until next milestone

Results Posted

Study results publicly available

November 17, 2017

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

6 years

First QC Date

December 28, 2007

Results QC Date

September 18, 2017

Last Update Submit

April 1, 2026

Conditions

Vertebrobasilar InsufficiencyIschemic Attack, TransientCerebrovascular DisorderBrain IschemiaStroke

Keywords

StrokeTIA (transient ischemic attack)BrainBlood FlowQuantitative magnetic resonance angiography (QMRA)

Outcome Measures

Primary Outcomes (1)

  • Fatal and Nonfatal Ischemic Stroke in the Vertebrobasilar Territory

    Definite fatal and nonfatal ischemic stroke in the vertebrobasilar territory

    up to 27 months

Study Arms (1)

Observation

Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neurology/Neurosurgery Clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California at Los Angeles - UCLA

Los Angeles, California, 90095, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Jeffrey Kramer, MDSC at Mercy Hospital

Chicago, Illinois, 60616, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Columbia University

New York, New York, 10032, United States

Location

UHN-Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (8)

  • Amin-Hanjani S, Du X, Zhao M, Walsh K, Malisch TW, Charbel FT. Use of quantitative magnetic resonance angiography to stratify stroke risk in symptomatic vertebrobasilar disease. Stroke. 2005 Jun;36(6):1140-5. doi: 10.1161/01.STR.0000166195.63276.7c. Epub 2005 May 12.

    PMID: 15890993BACKGROUND

  • Amin-Hanjani S, Rose-Finnell L, Richardson D, Ruland S, Pandey D, Thulborn KR, Liebeskind DS, Zipfel GJ, Elkind MS, Kramer J, Silver FL, Kasner SE, Caplan LR, Derdeyn CP, Gorelick PB, Charbel FT; VERiTAS Study Group. Vertebrobasilar Flow Evaluation and Risk of Transient Ischaemic Attack and Stroke study (VERiTAS): rationale and design. Int J Stroke. 2010 Dec;5(6):499-505. doi: 10.1111/j.1747-4949.2010.00528.x.

    PMID: 21050408BACKGROUND

  • Amin-Hanjani S, Du X, Rose-Finnell L, Pandey DK, Richardson D, Thulborn KR, Elkind MS, Zipfel GJ, Liebeskind DS, Silver FL, Kasner SE, Aletich VA, Caplan LR, Derdeyn CP, Gorelick PB, Charbel FT; VERiTAS Study Group. Hemodynamic Features of Symptomatic Vertebrobasilar Disease. Stroke. 2015 Jul;46(7):1850-6. doi: 10.1161/STROKEAHA.115.009215. Epub 2015 May 14.

    PMID: 25977279RESULT

  • Amin-Hanjani S, Pandey DK, Rose-Finnell L, Du X, Richardson D, Thulborn KR, Elkind MS, Zipfel GJ, Liebeskind DS, Silver FL, Kasner SE, Aletich VA, Caplan LR, Derdeyn CP, Gorelick PB, Charbel FT; Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke Study Group. Effect of Hemodynamics on Stroke Risk in Symptomatic Atherosclerotic Vertebrobasilar Occlusive Disease. JAMA Neurol. 2016 Feb;73(2):178-85. doi: 10.1001/jamaneurol.2015.3772.

    PMID: 26720181RESULT

  • Amin-Hanjani S, Turan TN, Du X, Pandey DK, Rose-Finnell L, Richardson D, Elkind MS, Zipfel GJ, Liebeskind DS, Silver FL, Kasner SE, Gorelick PB, Charbel FT, Derdeyn CP; VERiTAS Study Group. Higher Stroke Risk with Lower Blood Pressure in Hemodynamic Vertebrobasilar Disease: Analysis from the VERiTAS Study. J Stroke Cerebrovasc Dis. 2017 Feb;26(2):403-410. doi: 10.1016/j.jstrokecerebrovasdis.2016.09.044. Epub 2016 Oct 28.

    PMID: 28029608RESULT

  • Amin-Hanjani S, See AP, Du X, Rose-Finnell L, Pandey DK, Chen YF, Elkind MSV, Zipfel GJ, Liebeskind DS, Silver FL, Kasner SE, Gorelick PB, Charbel FT, Derdeyn CP; VERiTAS Study Group. Natural History of Hemodynamics in Vertebrobasilar Disease: Temporal Changes in the VERiTAS Study Cohort. Stroke. 2020 Nov;51(11):3295-3301. doi: 10.1161/STROKEAHA.120.029909. Epub 2020 Oct 9.

    PMID: 33032489DERIVED

  • Amin-Hanjani S, Stapleton CJ, Du X, Rose-Finnell L, Pandey DK, Elkind MSV, Zipfel GJ, Liebeskind DS, Silver FL, Kasner SE, Caplan LR, Derdeyn CP, Gorelick PB, Charbel FT; VERiTAS Study Group. Hypoperfusion Symptoms Poorly Predict Hemodynamic Compromise and Stroke Risk in Vertebrobasilar Disease. Stroke. 2019 Feb;50(2):495-497. doi: 10.1161/STROKEAHA.118.023101.

    PMID: 30580717DERIVED

  • Esfahani DR, Pandey D, Du X, Rose-Finnell L, Charbel FT, Derdeyn CP, Amin-Hanjani S; VERiTAS Study Group. Cost-Effectiveness of Quantitative Magnetic Resonance Angiography Screening and Submaximal Angioplasty for Symptomatic Vertebrobasilar Disease. Stroke. 2018 Aug;49(8):1953-1959. doi: 10.1161/STROKEAHA.118.022339.

    PMID: 30012817DERIVED

Related Links

MeSH Terms

Conditions

Vertebrobasilar InsufficiencyIschemic Attack, TransientCerebrovascular DisordersBrain IschemiaStroke

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Sepideh Amin-Hanjani, MD
Organization
University of Illinois at Chicago
hanjani@uic.edu
312-996-4842

Study Officials

  • Sepideh Amin-Hanjani, MD

    University of Illinois, Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 11, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

April 15, 2026

Results First Posted

November 17, 2017

Record last verified: 2026-04

Locations

US(5)CA(1)