Vertigo, PeripheralNCT04070664
Thiol/Disulphide Homeostasis and Albumin in Vertigo
An observational study of Vertigo, Peripheral and Vertigo, Central Origin, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Vertigo is a common complaint in the Emergency Department (ED). The differential diagnosis of central and peripheral vertigo is a difficult issue that directly affects mortality. Read more about this study
- Who is it for?
- Ages 51 to 85 years
- Conditions the study is for
- Vertigo, Peripheral, Vertigo, Central Origin, Oxidative Stress
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 31 Dec 2018
- 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 51 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were admitted to the ED with acute onset vertigo of less than 24 hours and who underwent brain MRI for differential diagnosis of peripheral or central vertigo
Who may be able to join
- Patients with complaint of vertigo
- Patients over18 years of age
Who cannot join
- Patients contraindicated for MRI due to metal prosthesis or claustrophobia
- Patients under 18 years of age
- Pregnant patients
- Tobacco users
- Patients exhibiting significant neurological signs or symptoms such as motor or sensory neurologic deficit, speech disorders, unconsciousness, or seizure
- Patients found to have any type of lesion such as a hematoma, mass, cyst, aneurysm, arteriovenous malformation, etc. other than ischemic infarcts on MRI
Show all 10Show fewer
- Patients with an ischemic lesion other than posterior fossa lesions
- Patients with any type of infection, including upper respiratory tract and ear infections
- Patients previously diagnosed with peripheral vertigo
- Patients where the cause of lightheadedness was blood pressure disorders, cardiac ischemic and arrhythmic disorders, thromboembolic diseases, metabolic disorders, trauma, etc. rather than central and peripheral vertigo.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, School of Medicine, Department of Emergency Medicine
Ankara, Çankaya, 06800
About this study
Official title: Evaluation of Thiol/Disulfide Homeostasis and Ischemia Modified Albumin Levels in the Differential Diagnosis of Central and Peripheral Vertigo
Vertigo is a common complaint in the Emergency Department (ED). The differential diagnosis of central and peripheral vertigo is a difficult issue that directly affects mortality. Magnetic resonance imaging (MRI) is the preferred diagnostic tool, but may not be suitable in all patients due to logistic and economic conditions. In this study, the investigators evaluated the role of thiol/disulfide homeostasis (TDH) parameters and ischemia modified albumin (IMA) levels to assist in the value of being used instead of MRI.
Read the detailed description
The study was conducted in the ED using a prospective, non-randomized method, and included patients with complaints of acute onset vertigo over 18 years of age and who underwent brain MRI. Pregnant women, smokers, and those with significant neurological signs were excluded. Patients with acute ischemia with MRI were included in the central vertigo group, and patients with normal MRI were included in the peripheral vertigo group. Blood samples for native thiol (NT), total thiol (TT), disulfide, and IMA were collected from all patients at admission. Statistical analyzes were performed with IBM SPSS Statistics for Windows 16.0 Package Program.
- Keywords
- Vertigo, Central vertigo, Peripheral vertigo, Thiol/disulfide homeostasis, Ischemia modified albumin, Differential diagnosis
- Medical subject headings
- Vertigo, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Central vertigo | Patients without any pathology on MRI were included in the peripheral vertigo group, and patients whose scans demonstrated acute ischemic infarct in the posterior fossa were included in the central vertigo group. | |
| Peripheral vertigo | Patients without any pathology on MRI were included in the peripheral vertigo group, and patients whose scans demonstrated acute ischemic infarct in the posterior fossa were included in the central vertigo group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress
Thiol/disulphide homeostasis
Measured: 6 months
Ischemic status
Ischemia modified albumin
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jul 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vertigo, PeripheralStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Training and Research Hospital
- Responsible party
- Principal investigator, Alp Şener, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070664
- Sponsor's protocol ID
- medybu137
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan for sharing IPD to other researchers.
Publications
Kartal AG, Yilmaz S, Yaka E, Pekdemir M, Sarisoy HT, Cekmen MB, Yuksel M. Diagnostic value of S100B protein in the differential diagnosis of acute vertigo in the emergency department. Acad Emerg Med. 2014 Jul;21(7):736-41. doi: 10.1111/acem.12420.
PubMed 25125270Bektas H, Vural G, Gumusyayla S, Deniz O, Alisik M, Erel O. Dynamic thiol-disulfide homeostasis in acute ischemic stroke patients. Acta Neurol Belg. 2016 Dec;116(4):489-494. doi: 10.1007/s13760-016-0598-1. Epub 2016 Jan 18.
PubMed 26782823Sahin E, Deveci I, Dinc ME, Ozker BY, Bicer C, Erel O. Oxidative Status in Patients with Benign Paroxysmal Positional Vertigo. J Int Adv Otol. 2018 Aug;14(2):299-303. doi: 10.5152/iao.2018.4756.
PubMed 30256204
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thiol/Disulfide Homeostasis and Ischemia Modified Albumin Levels in the Differential Diagnosis of Central and Peripheral Vertigo
- ClinicalTrials.gov ID
- NCT04070664
- Acronym / sponsor ID
- medybu137
- Keywords
- Vertigo, Central vertigo, Peripheral vertigo, Thiol/disulfide homeostasis, Ischemia modified albumin, Differential diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Ankara Training and Research Hospital
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Aug 2019 (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.
Vertigo is a common complaint in the Emergency Department (ED). The differential diagnosis of central and peripheral vertigo is a difficult issue that directly affects mortality. Magnetic resonance imaging (MRI) is the preferred diagnostic tool, but may not be suitable in all patients due to logistic and economic conditions. In this study, the investigators evaluated the role of thiol/disulfide homeostasis (TDH) parameters and ischemia modified albumin (IMA) levels to assist in the value of being used instead of MRI.
Detailed description
The study was conducted in the ED using a prospective, non-randomized method, and included patients with complaints of acute onset vertigo over 18 years of age and who underwent brain MRI. Pregnant women, smokers, and those with significant neurological signs were excluded. Patients with acute ischemia with MRI were included in the central vertigo group, and patients with normal MRI were included in the peripheral vertigo group. Blood samples for native thiol (NT), total thiol (TT), disulfide, and IMA were collected from all patients at admission. Statistical analyzes were performed with IBM SPSS Statistics for Windows 16.0 Package Program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central vertigo | – | –Patients without any pathology on MRI were included in the peripheral vertigo group, and patients whose scans demonstrated acute ischemic infarct in the posterior fossa were included in the central vertigo group. |
| Peripheral vertigo | – | –Patients without any pathology on MRI were included in the peripheral vertigo group, and patients whose scans demonstrated acute ischemic infarct in the posterior fossa were included in the central vertigo group. |
Who may qualify
- Ages
- 51 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were admitted to the ED with acute onset vertigo of less than 24 hours and who underwent brain MRI for differential diagnosis of peripheral or central vertigo
Key inclusion criteria (2 listed)
- Patients with complaint of vertigo
- Patients over18 years of age
Key exclusion criteria (10 listed)
- Patients contraindicated for MRI due to metal prosthesis or claustrophobia
- Patients under 18 years of age
- Pregnant patients
- Tobacco users
- Patients exhibiting significant neurological signs or symptoms such as motor or sensory neurologic deficit, speech disorders, unconsciousness, or seizure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxidative stress
Time frame: 6 months
Thiol/disulphide homeostasis
Ischemic status
Time frame: 6 months
Ischemia modified albumin
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 28 Aug 2019.
- Background: PubMed 25125270Kartal AG, Yilmaz S, Yaka E, Pekdemir M, Sarisoy HT, Cekmen MB, Yuksel M. Diagnostic value of S100B protein in the differential diagnosis of acute vertigo in the emergency department. Acad Emerg Med. 2014 Jul;21(7):736-41. doi: 10.1111/acem.12420.
- Background: PubMed 26782823Bektas H, Vural G, Gumusyayla S, Deniz O, Alisik M, Erel O. Dynamic thiol-disulfide homeostasis in acute ischemic stroke patients. Acta Neurol Belg. 2016 Dec;116(4):489-494. doi: 10.1007/s13760-016-0598-1. Epub 2016 Jan 18.
- Background: PubMed 30256204Sahin E, Deveci I, Dinc ME, Ozker BY, Bicer C, Erel O. Oxidative Status in Patients with Benign Paroxysmal Positional Vertigo. J Int Adv Otol. 2018 Aug;14(2):299-303. doi: 10.5152/iao.2018.4756.
- Individual participant dataSharing planned: No. There is no plan for sharing IPD to other researchers.
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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, Peripheral and Vertigo, Central Origin, run by Ankara City Hospital Bilkent 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 2 inclusion and 10 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 28 Aug 2019. 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?
Oxidative stress (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04070664, which also lists 3 linked publications.
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 28 Aug 2019.