search
Back to results

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
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vertebrobasilar Insufficiency focused on measuring vertebrobasilar-insufficiency-transcranial-doppler

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. patients with vertigo of central origin, syncopal attacks, frequent imbalance that not related to aural origin.
  2. clinical examination and imaging (MRI or CT) with the diagnosis standard of vertebrobasilar insufficiency including vertebrobasilar stroke and vertebrobasilar TIA.
  3. patients with abnormal lipogram and cervical spondylosis
  4. patients aged > 45 years old of both sex.

Exclusion Criteria:

  1. subjective complain of aural vertigo or test to exclude aural vertigo.
  2. patients with malignant tumor.
  3. pregnant or lactating women.
  4. 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

    First Posted
    August 16, 2021
    Last Updated
    August 30, 2021
    Sponsor
    Assiut University
    search

    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

    We'll reach out to this number within 24 hrs