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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00590980
First Posted: January 11, 2008
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Sepideh Amin-Hanjani, University of Illinois at Chicago
Results First Submitted: September 18, 2017  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Vertebrobasilar Insufficiency
Ischemic Attack, Transient
Cerebrovascular Disorder
Brain Ischemia
Stroke

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Study Participants Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.

Participant Flow:   Overall Study
    All Study Participants
STARTED   82 
COMPLETED   72 
NOT COMPLETED   10 
Did not meet all inclusion criteria                10 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population consists of all participants meeting all inclusion/exclusion criteria

Reporting Groups
  Description
Study Participants Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.

Baseline Measures
   Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 72 
Age 
[Units: Years]
Mean (Full Range)
 65.6 
 (39 to 89) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      32  44.4% 
Male      40  55.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      8  11.1% 
Not Hispanic or Latino      64  88.9% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      4   5.6% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      18  25.0% 
White      49  68.1% 
More than one race      0   0.0% 
Unknown or Not Reported      1   1.4% 
Region of Enrollment 
[Units: Participants]
 
Canada   6 
United States   66 


  Outcome Measures

1.  Primary:   Fatal and Nonfatal Ischemic Stroke in the Vertebrobasilar Territory   [ Time Frame: up to 27 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sepideh Amin-Hanjani, MD
Organization: University of Illinois at Chicago
phone: 312-996-4842
e-mail: hanjani@uic.edu


Publications of Results:
Other Publications:

Responsible Party: Sepideh Amin-Hanjani, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00590980     History of Changes
Other Study ID Numbers: 2006-0599
5R01NS059745 ( U.S. NIH Grant/Contract )
First Submitted: December 28, 2007
First Posted: January 11, 2008
Results First Submitted: September 18, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017