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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04070664
Other study ID # medybu137
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date December 31, 2018

Study information

Verified date August 2019
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 51 Years to 85 Years
Eligibility 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 Design


Locations

Country Name City State
Turkey Ankara Yildirim Beyazit University, School of Medicine, Department of Emergency Medicine Ankara Çankaya

Sponsors (2)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent Ankara Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Epub 2016 Jan 18. — View Citation

Kartal AG, Yilmaz S, Yaka E, Pekdemir M, Sarisoy HT, Çekmen MB, Yüksel 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. — View Citation

Sahin E, Deveci I, Dinç ME, Özker BY, Biçer C, Erel Ö. 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Oxidative stress Thiol/disulphide homeostasis 6 months
Primary Ischemic status Ischemia modified albumin 6 months
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