- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070664
Thiol/Disulphide Homeostasis and Albumin in Vertigo
August 24, 2019 updated by: Alp Şener, Ankara City Hospital Bilkent
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Çankaya
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Ankara, Çankaya, Turkey, 06800
- Ankara Yıldırım Beyazıt University, School of Medicine, Department of Emergency Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
49 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- Patients with complaint of vertigo
- Patients over18 years of age
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxidative stress
Time Frame: 6 months
|
Thiol/disulphide homeostasis
|
6 months
|
Ischemic status
Time Frame: 6 months
|
Ischemia modified albumin
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Bektas 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.
- Sahin 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
August 22, 2019
First Submitted That Met QC Criteria
August 24, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 24, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- medybu137
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is no plan for sharing IPD to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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