Vertebrobasilar InsufficiencyNCT05019391
Clinical and Radiological Evaluation of Patients With Vertebrobasilar Insufficiency in Assiut University Hospital
A study testing transcranial doppler in people with Vertebrobasilar Insufficiency, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Vertebrobasilar Insufficiency
- What is being tested?
- transcranial doppler
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- subjective complain of aural vertigo or test to exclude aural vertigo.
- patients with malignant tumor.
- pregnant or lactating women.
- cognitive impairment and mental illness.
About this study
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.
Read the 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.
- Conditions
- Vertebrobasilar Insufficiency
- Being tested
- transcranial doppler
- Keywords
- vertebrobasilar-insufficiency-transcranial-doppler
- Medical subject headings
- Vertebrobasilar Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial dopplerDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vertebrobasilar InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019391
- Sponsor's protocol ID
- vertebrobasilar insufficiency
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20396469
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Evaluation of Patients With Vertebrobasilar Insufficiency in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05019391
- Acronym / sponsor ID
- vertebrobasilar insufficiency
- Conditions
- Vertebrobasilar Insufficiency
- Keywords
- vertebrobasilar-insufficiency-transcranial-doppler
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- 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.
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- subjective complain of aural vertigo or test to exclude aural vertigo.
- patients with malignant tumor.
- pregnant or lactating women.
- cognitive impairment and mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial dopplerit 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 | Device | – |
Primary outcome
Detection and estimation of risk factors for vertebrobasilar insufficiency patients
Time frame: 3 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Results publication: PubMed 20396469Caplan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial doppler in people with Vertebrobasilar Insufficiency, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection and estimation of risk factors for vertebrobasilar insufficiency patients (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.