- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04734223
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
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Di̇yarbakir, Turkey, 21070
- Sağlik Bilimleri Üniversitesi Training and Research Hospital
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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
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 |
Intervention / Treatment |
|---|---|
|
Group 1
The first group consisted of 46 patients whose neuroimaging findings demonstrated acute/subacute infarction, bleeding, encephalitis, and venous sinus thrombosis
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MR and BT Imaging
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Group 2
The 2nd group (N=390) was obtained by subtracting the 1st group from all cases.
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MR and BT Imaging
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Group 3
The third group (N = 189) consisted of patients of the first group and patients with chronic ischemic changes observed in neuroimaging
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MR and BT Imaging
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Group 4
The 4th group (N=247) was obtained by subtracting the 3rd group from all cases.
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MR and BT Imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of acute thromboembolism in COVID-19 patients undergoing neuroimaging
Time Frame: Between April and December 2020
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Acute thromboembolic events are common in COVID-19 subjects undergoing neuroimaging, potentially due to an increased procoagulant process.
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Between April and December 2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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)
April 1, 2020
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
January 29, 2021
First Submitted That Met QC Criteria
February 1, 2021
First Posted (Actual)
February 2, 2021
Study Record Updates
Last Update Posted (Actual)
February 4, 2021
Last Update Submitted That Met QC Criteria
February 1, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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