NCT05019391

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

August 16, 2021

Last Update Submit

August 30, 2021

Conditions

Keywords

vertebrobasilar-insufficiency-transcranial-doppler

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • subjective complain of aural vertigo or test to exclude aural vertigo.
  • patients with malignant tumor.
  • pregnant or lactating women.
  • cognitive impairment and mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Vertebrobasilar Insufficiency

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 24, 2021

Study Start

November 1, 2021

Primary Completion

November 1, 2023

Study Completion

September 1, 2024

Last Updated

September 2, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share