Neuroimaging Findings in Patients With COVID-19

February 1, 2021 updated by: Seyhmus Kavak, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Correlation of Neuroimaging Findings With Clinical Presentation and Laboratory Data in Patients With COVID-19: A Single Center Study

This study aimed to discuss the neuroimaging findings and indications, epidemiological data, laboratory values, and the relationship of these variables with mortality in patients with COVID-19.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

COVID-19 can present as neurological symptoms such as anosmia, headache, taste perversion, dizziness, syncope, and altered state of consciousness. It has been reported in previous studies that thromboembolic ischemic and hemorrhagic strokes associated with COVID-19 have been observed in the early period. It has been suggested that conditions characterized by neurological sequelae, such as encephalitis and encephalopathy, ataxic seizures, Guillain-Barré syndrome (GBS), demyelinating diseases, and neuromuscular disorders may occur in the longer term.In the present study, the investigators aimed to reveal the findings of neuroimaging analyses performed in patients followed up with a diagnosis of COVID-19 who had neurological symptoms, discuss the relationship of these findings with laboratory and epidemiological data, and emphasize that CNS involvement in these patients should not be overlooked. In this study, 436 patients with COVID-19 who underwent at least one neuroimaging procedure during April 2020-December 2020 due to neurological symptoms and whose diagnosis was confirmed by reverse transcriptase-polymerase chain reaction test were included. Although computed tomography was predominantly used for imaging, magnetic resonance imaging was also used when necessary. The patients were grouped based on imaging findings, and statistical evaluations were made between the groups.

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.
436

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
      • Di̇yarbakir, Turkey, 21070
        • Sağlik Bilimleri Üniversitesi Training and Research Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects more than 18 years old and who are followed up and treated with the diagnosis of COVID-19 in Sağlık Bilimleri Üniversitesi Gazi Yaşargil Training and Research Hospital will be included.

Description

Inclusion Criteria:

  • COVID-19 RT-PCR positivity-
  • older than 18 years old

Exclusion Criteria:

  • younger than 18 years old

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

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.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
The first group consisted of 46 patients whose neuroimaging findings demonstrated acute/subacute infarction, bleeding, encephalitis, and venous sinus thrombosis
Diagnostic test: Neuroimaging Findings in Patients With COVID-19
MR and BT Imaging
Group 2
The 2nd group (N=390) was obtained by subtracting the 1st group from all cases.
Diagnostic test: Neuroimaging Findings in Patients With COVID-19
MR and BT Imaging
Group 3
The third group (N = 189) consisted of patients of the first group and patients with chronic ischemic changes observed in neuroimaging
Diagnostic test: Neuroimaging Findings in Patients With COVID-19
MR and BT Imaging
Group 4
The 4th group (N=247) was obtained by subtracting the 3rd group from all cases.
Diagnostic test: Neuroimaging Findings in Patients With COVID-19
MR and BT Imaging

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
Frequency of acute thromboembolism in COVID-19 patients undergoing neuroimaging
Time Frame: Between April and December 2020
Acute thromboembolic events are common in COVID-19 subjects undergoing neuroimaging, potentially due to an increased procoagulant process.
Between April and December 2020

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.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ŞEYHMUS KAVAK, MD, SAGLIK BİLİMLERİ ÜNİVERSİTESİ TRAINING AND RESEARCH HOSPITAL H

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.
April 1, 2020

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, 2020

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, 2020

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).
January 29, 2021

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.
February 1, 2021

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.
February 2, 2021

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.
February 4, 2021

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.
February 1, 2021

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.
February 1, 2021

More Information

Terms related to this study

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.
  • 09.25.2020/587

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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