NeuroimagingNCT04734223
Neuroimaging Findings in Patients With COVID-19
An observational study of Neuroimaging and COVID-19, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuroimaging, COVID-19
- What is being tested?
- Neuroimaging Findings in Patients With COVID-19
- How many people
- 436 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- COVID-19 RT-PCR positivity-
- older than 18 years old
Who cannot join
- younger than 18 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlik Bilimleri Üniversitesi Training and Research Hospital
Diyarbakır, 21070
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuroimaging, COVID-19
- Being tested
- Neuroimaging Findings in Patients With COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroimaging Findings in Patients With COVID-19Diagnostic test
MR and BT Imaging
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The first group consisted of 46 patients whose neuroimaging findings demonstrated acute/subacute infarction, bleeding, encephalitis, and venous sinus thrombosis Receives: Diagnostic Test: Neuroimaging Findings in Patients With COVID-19 | |
| Group 2 | The 2nd group (N=390) was obtained by subtracting the 1st group from all cases. Receives: Diagnostic Test: Neuroimaging Findings in Patients With COVID-19 | |
| Group 3 | The third group (N = 189) consisted of patients of the first group and patients with chronic ischemic changes observed in neuroimaging Receives: Diagnostic Test: Neuroimaging Findings in Patients With COVID-19 | |
| Group 4 | The 4th group (N=247) was obtained by subtracting the 3rd group from all cases. Receives: Diagnostic Test: Neuroimaging Findings in Patients With COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of acute thromboembolism in COVID-19 patients undergoing neuroimaging
Acute thromboembolic events are common in COVID-19 subjects undergoing neuroimaging, potentially due to an increased procoagulant process.
Measured: Between April and December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Apr 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroimagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyhmus Kavak, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- ŞEYHMUS KAVAK, MD, Principal investigator, SAGLIK BİLİMLERİ ÜNİVERSİTESİ TRAINING AND RESEARCH HOSPITAL H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734223
- Sponsor's protocol ID
- 09.25.2020/587
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Neuroimaging Findings With Clinical Presentation and Laboratory Data in Patients With COVID-19: A Single Center Study
- ClinicalTrials.gov ID
- NCT04734223
- Acronym / sponsor ID
- 09.25.2020/587
- Conditions
- Neuroimaging, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Neuroimaging Findings in Patients With COVID-19The first group consisted of 46 patients whose neuroimaging findings demonstrated acute/subacute infarction, bleeding, encephalitis, and venous sinus thrombosis |
| Group 2 | – | Diagnostic Test: Neuroimaging Findings in Patients With COVID-19The 2nd group (N=390) was obtained by subtracting the 1st group from all cases. |
| Group 3 | – | Diagnostic Test: Neuroimaging Findings in Patients With COVID-19The third group (N = 189) consisted of patients of the first group and patients with chronic ischemic changes observed in neuroimaging |
| Group 4 | – | Diagnostic Test: Neuroimaging Findings in Patients With COVID-19The 4th group (N=247) was obtained by subtracting the 3rd group from all cases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- COVID-19 RT-PCR positivity-
- older than 18 years old
Key exclusion criteria (1 listed)
- younger than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroimaging Findings in Patients With COVID-19MR and BT Imaging | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ŞEYHMUS KAVAK, MD principal investigator
SAGLIK BİLİMLERİ ÜNİVERSİTESİ TRAINING AND RESEARCH HOSPITAL H
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroimaging and COVID-19, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of acute thromboembolism in COVID-19 patients undergoing neuroimaging (time frame: Between April and December 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.