VertigoNCT05196685
Is Carotid-Vertebral Doppler Ultrasonography Necessary for Patients With Vertigo?
An observational study of Vertigo and Carotid Artery Diseases, run by Pamukkale University at 1 site in Turkey (Türkiye).
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". Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vertigo, Carotid Artery Diseases
- What is being tested?
- Carotid Doppler USG
- How many people
- 195 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 31 Aug 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- All patients who have a vascular problem and doppler USG.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Vertigo, Carotid Artery Diseases
- Being tested
- Carotid Doppler USG
- Keywords
- Vertigo, Imbalance, Doppler Ultrasonography, Carotid Artery, Vertebral Artery
- Medical subject headings
- Vertigo, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Vertigo | Patients who have Carotid Doppler Ultrasonography and Vertigo screening test scores of 1 and above will be sent to ENT Receives: Diagnostic Test: Carotid Doppler USG | |
| Group control | Patients who have Carotid Doppler Ultrasonography and Vertigo screening test score below 1 Receives: Diagnostic Test: Carotid Doppler USG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Feb 2021
- Primary completion1 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazıl Necdet Ardıç, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196685
- Sponsor's protocol ID
- 10
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Carotid-Vertebral Doppler Ultrasonography Necessary for Patients With Vertigo?
- ClinicalTrials.gov ID
- NCT05196685
- Acronym / sponsor ID
- 10
- Conditions
- Vertigo, Carotid Artery Diseases
- Keywords
- Vertigo, Imbalance, Doppler Ultrasonography, Carotid Artery, Vertebral Artery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 19 Jan 2022 (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.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Vertigo | – | Diagnostic Test: Carotid Doppler USGPatients who have Carotid Doppler Ultrasonography and Vertigo screening test scores of 1 and above will be sent to ENT |
| Group control | – | Diagnostic Test: Carotid Doppler USGPatients who have Carotid Doppler Ultrasonography and Vertigo screening test score below 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients who have a vascular problem and doppler USG.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Carotid Doppler USGAll 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. | Diagnostic test | Group Vertigo, Group control |
Primary outcome
Carotid Stenosis
Time frame: 1 year
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.
Resistive Index
Time frame: 1 year
Measurements are taken from vertebral artery and formulated as below. Resistive Index = peak systolic velocity - end diastolic velocity] / peak systolic velocity
Intima Media Thickness
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo and Carotid Artery Diseases, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Carotid Stenosis (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2023.