NCT05196685

Brief Summary

This study will be carried out prospectively on patients who applied to the cardiovascular surgery polyclinic and the carotid-vertebral artery doppler ultrasound due to the vascular problem. All patients will fill "Balance Disorder Scan Survey" and "Vertigo-Dizziness Imbalance Questionnaire-SS". Patients who score 1 and more are directed to the ear nose throat polyclinic and detailed differential diagnosis. Those who score 0 will be in control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

January 3, 2022

Last Update Submit

January 14, 2023

Conditions

Keywords

VertigoImbalanceDoppler UltrasonographyCarotid ArteryVertebral Artery

Outcome Measures

Primary Outcomes (3)

  • Carotid Stenosis

    ECST for Carotid Stenosis measurement will be used. In the ECST the estimated normal lumen diameter at the site of the lesion, based on a visual impression of where the normal arterial wall is before development of the stenosis, is used.

    1 year

  • Resistive Index

    Measurements are taken from vertebral artery and formulated as below. Resistive Index = peak systolic velocity - end diastolic velocity\] / peak systolic velocity

    1 year

  • Intima Media Thickness

    The intima-media thickness will be measured 1 cm proximal to the start of the carotid bulb dilatation on the CCA in the far wall. Using the cine-loop function, an optimal longitudinal freeze-frame image in the end-diastolic state is measured manually.

    1 year

Study Arms (2)

Group Vertigo

Patients who have Carotid Doppler Ultrasonography and Vertigo screening test scores of 1 and above will be sent to ENT

Diagnostic Test: Carotid Doppler USG

Group control

Patients who have Carotid Doppler Ultrasonography and Vertigo screening test score below 1

Diagnostic Test: Carotid Doppler USG

Interventions

Carotid Doppler USGDIAGNOSTIC_TEST

All Doppler ultrasonography measurements will be made in a dimly lit room at room temperature, with the patient in the supine position, the head slightly hyperextended, the patient looking to the left when measuring the right side, and the patient looking to the right when measuring the left side. In all patients, common carotid artery (CCA), internal carotid artery (ICA) and vertebral artery (VA) gray scale and color Doppler ultrasonography wşll be performed using the GE 9L Linear Probe. Color Doppler examination will be performed with a frequency of 4.0/8.0 MHz.

Group VertigoGroup control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will be conducted prospectively on patients who apply to the Cardiovascular Surgery outpatient clinic and undergo Carotid-vertebral artery Doppler ultrasound due to vascular problems.

You may qualify if:

  • All patients who have a vascular problem and doppler USG.

You may not qualify if:

  • Patients with impaired cooperation, history of malignancy, presence of central nervous system pathology, presence of neurological disease affecting balance in the history, patients whose use of glasses may cause problems (epilepsy, vision loss, etc.) were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

VertigoCarotid Artery Diseases

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 19, 2022

Study Start

February 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 31, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations