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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05196685
Other study ID # 10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date August 31, 2022

Study information

Verified date January 2023
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Right and left carotid artery flow velocities, intima-media thicknesses (IMT), presence of plaque, vertebral artery flow velocities, and vertebral artery resistance indexes (RI) will be recorded in all patients. Risk factor analysis, Vertigo Symptom Scale (VSS) and Dizziness Handicap Inventory (DHI-S) questionnaires will be applied to the patients in the ENT outpatient clinic. The differential diagnosis of vertigo will be made by performing detailed balance examinations and advanced balance tests.


Recruitment information / eligibility

Status Completed
Enrollment 195
Est. completion date August 31, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients who have a vascular problem and doppler USG. Exclusion Criteria: 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Carotid Doppler USG
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 wsll be performed using the GE 9L Linear Probe. Color Doppler examination will be performed with a frequency of 4.0/8.0 MHz.

Locations

Country Name City State
Turkey Pamukkale University Denizli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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