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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
    • Çankaya
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

47 years to 81 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ankara Training and Research Hospital

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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