Clinical and Radiological Evaluation of Patients With Vertebrobasilar Insufficiency in Assiut University Hospital
Primary Purpose
Vertebrobasilar Insufficiency
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcranial doppler
Sponsored by
About this trial
This is an interventional diagnostic trial for Vertebrobasilar Insufficiency focused on measuring vertebrobasilar-insufficiency-transcranial-doppler
Eligibility Criteria
Inclusion Criteria:
- patients with vertigo of central origin, syncopal attacks, frequent imbalance that not related to aural origin.
- clinical examination and imaging (MRI or CT) with the diagnosis standard of vertebrobasilar insufficiency including vertebrobasilar stroke and vertebrobasilar TIA.
- patients with abnormal lipogram and cervical spondylosis
- patients aged > 45 years old of both sex.
Exclusion Criteria:
- subjective complain of aural vertigo or test to exclude aural vertigo.
- patients with malignant tumor.
- pregnant or lactating women.
- cognitive impairment and mental illness.
Sites / Locations
Outcomes
Primary Outcome Measures
Detection and estimation of risk factors for vertebrobasilar insufficiency patients
Evaluation and detection of possible risk factors that may lead to vertebrobasilar insufficiency by using Doppler ultrasound and detection of rate of vertebrobasilar insufficiency due to central vertigo or frequent imbalance attacks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05019391
Brief Title
Clinical and Radiological Evaluation of Patients With Vertebrobasilar Insufficiency in Assiut University Hospital
Official Title
Clinical and Radiological Evaluation of Patients With Vertebrobasilar Insufficiency in Assiut University Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical and radiological evaluation including transcranial Doppler of vertebral arteries of patients with vertebrobasilar insufficiency attending assiut university hospital and assessment of possible risk factors that may lead to vertebrobasilar insufficiency.
Detailed Description
Vertebrobasilar insufficiency (VBI) is defined by inadequate blood flow through the posterior circulation of the brain, supplied by the 2 vertebral arteries that merge to form the basilar artery. Transient ischemic attacks in the vertebrobasilar system represent 20% of all transient ischemic attacks, Their diagnosis is more difficult than that of ischemic attacks in the anterior circulation because its manifestations are subjective and difficult to quantify. Although traditionally VB stroke is regarded as having a more benign outcome when compared to anterior circulation stroke, data is still conflicting, with some studies showing a higher impairment in VB stroke patients with 21% of death or major disability at 3 months. Transient ischemic attacks and, more rarely, infarcts in the posterior circulation may be due to subclavian steal syndrome. Basilar artery transient ischemic attacks usually occur after the six decade, syncopal attacks occur in about 10% sudden in onset and brief in duration. Regarding the clinical presentation of VB stroke, the common symptoms are dizziness, unilateral limb weakness, headache, vomiting and nausea; as for clinical signs, the most frequent are unilateral limb weakness, gait ataxia, unilateral limb ataxia, dysarthria and nystagmus. Previously, there was no simple and effective method for the detection of VBI, but in recent years, with the development and progress of medical technology and the emergence of Transcranial Doppler (TCD), it provides an accurate, noninvasive, and simple method for the diagnosis of VBI. Through the diagnosis results, it will be clear about the blood flow status of single vessel and vascular compliance, which is helpful for accurate reflection of the subtle changes of VBI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebrobasilar Insufficiency
Keywords
vertebrobasilar-insufficiency-transcranial-doppler
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A cohort study will be performed on at least 100 patients presented with vertebrobasilar insufficiency including vertebrobasilar stroke or vertebrobasilar TIA who will be admitted in department of neurology in assiut university hospital.
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
transcranial doppler
Intervention Description
it provides an accurate, noninvasive, and simple method for the diagnosis of VBI. Through the diagnosis results, it will be clear about the blood flow status of single vessel and vascular compliance, which is helpful for accurate reflection of the subtle changes of VBI
Primary Outcome Measure Information:
Title
Detection and estimation of risk factors for vertebrobasilar insufficiency patients
Description
Evaluation and detection of possible risk factors that may lead to vertebrobasilar insufficiency by using Doppler ultrasound and detection of rate of vertebrobasilar insufficiency due to central vertigo or frequent imbalance attacks
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with vertigo of central origin, syncopal attacks, frequent imbalance that not related to aural origin.
clinical examination and imaging (MRI or CT) with the diagnosis standard of vertebrobasilar insufficiency including vertebrobasilar stroke and vertebrobasilar TIA.
patients with abnormal lipogram and cervical spondylosis
patients aged > 45 years old of both sex.
Exclusion Criteria:
subjective complain of aural vertigo or test to exclude aural vertigo.
patients with malignant tumor.
pregnant or lactating women.
cognitive impairment and mental illness.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20396469
Citation
Caplan L, Chung CS, Wityk R, Glass T, Tapia J, Pazdera L, Chang HM, Dashe J, Chaves C, Vemmos K, Leary M, Dewitt L, Pessin M. New England medical center posterior circulation stroke registry: I. Methods, data base, distribution of brain lesions, stroke mechanisms, and outcomes. J Clin Neurol. 2005 Apr;1(1):14-30. doi: 10.3988/jcn.2005.1.1.14. Epub 2005 Apr 30.
Results Reference
result
Learn more about this trial
Clinical and Radiological Evaluation of Patients With Vertebrobasilar Insufficiency in Assiut University Hospital
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