Clinical and Radiological Evaluation of Patients With Vertebrobasilar Insufficiency in Assiut University Hospital

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vertebrobasilar Insufficiency
• Intervention / Treatment: Device: transcranial doppler

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 years

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 21, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: vertebrobasilar-insufficiency-transcranial-doppler
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Vertebrobasilar Insufficiency
• Other Study ID Numbers: vertebrobasilar insufficiency

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No