NCT04070664

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

August 22, 2019

Last Update Submit

August 24, 2019

Conditions

Keywords

VertigoCentral vertigoPeripheral vertigoThiol/disulfide homeostasisIschemia modified albuminDifferential diagnosis

Outcome Measures

Primary Outcomes (2)

  • Oxidative stress

    Thiol/disulphide homeostasis

    6 months

  • Ischemic status

    Ischemia modified albumin

    6 months

Study Arms (2)

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.

Eligibility Criteria

Age51 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients with complaint of vertigo
  • Patients over18 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University, School of Medicine, Department of Emergency Medicine

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 25125270BACKGROUND
  • 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.

    PMID: 26782823BACKGROUND
  • 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.

    PMID: 30256204BACKGROUND

Biospecimen

Retention: NONE RETAINED

Venous blood samples

MeSH Terms

Conditions

VertigoDisease

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

July 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

There is no plan for sharing IPD to other researchers.

Locations