UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041226 |
|---|---|
| Receipt number | R000045903 |
| Scientific Title | Study of clinical characteristics of acute stroke with COVID-19 |
| Date of disclosure of the study information | 2020/07/27 |
| Last modified on | 2024/01/28 09:57:10 |
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Basic information
Public title
Study of clinical characteristics of acute stroke with COVID-19
Acronym
Study of clinical characteristics of acute stroke with COVID-19
Scientific Title
Study of clinical characteristics of acute stroke with COVID-19
Scientific Title:Acronym
Study of acute stroke with COVID-19
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Neurosurgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the characteristics of patients with stroke in confirmed COVID-19
Basic objectives2
Others
Basic objectives -Others
To study the management, treatment, and outcome of patients with stroke in confirmed COVID-19
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The clinical characteristics of patients with acute stroke for confirmed COVID-19
Key secondary outcomes
History, medications administered at admission (onset for hospital-onset patients), specific treatment for COVID-19, data at admission, laboratory values (at admission), pneumonia at stroke onset, ventilator (including Bipap) use, ECMO use, stroke characteristics, details of revascularization procedures, outcome
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with acute stroke in confirmed COVID-19
2) Positive results for COVID-19 based on reverse transcriptase-polymerase chain reaction (RT-PCR) after patients were admitted with acute stroke (including hospital-acquired infection)
Key exclusion criteria
Patients judged as inappropriate for this study by investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazumi |
| Middle name | |
| Last name | Kimura |
Organization
Nippon Medical School
Division name
department of neurology
Zip code
1138603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
k-kimura@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nishiyama |
Organization
Nippon Medical School
Division name
department of neurology
Zip code
1138603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
Homepage URL
nomo16@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
the Japan Stroke Society
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School IRB
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
0338222131
c-ethics@nms.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0022510X23023341
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0022510X23023341
Number of participants that the trial has enrolled
159
Results
Ischemic stroke and TIA (n=133) were analyzed separately. Among patients with ischemic stroke and TIA, 30% had cardioembolism, 18% had large-artery atherosclerosis, 10% had small-vessel occlusion, and 42% had a cryptogenic stroke or ESUS. One-third (34%) presented with LVO of the internal carotid artery, middle cerebral artery M1, or basilar artery. Poor outcomes included age, ischemic heart disease (IHD) history, moderate to severe pneumonia, an NIHSS score at baseline, LVO , and log10 D-dimer .
Results date posted
| 2023 | Year | 07 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We included 159 stroke cases (131 ischemic stroke, 2 transient ischemic attack (TIA), 21 intracranial hemorrhage, and 5 subarachnoid hemorrhage) and collected their clinical characteristics. Of the 159 patients, the mean age was 70.6 years, with 66% being men. Median NIHSS at baseline was 7.
Participant flow
This prospective, multicenter nationwide observational study of patients with COVID-19-related stroke involving 563 primary stroke centers in Japan was conducted between July 8, 2020, and May 31, 2022.
Adverse events
Nothing in particular
Outcome measures
Poor outcome (mRS score of 5-6) at discharge and mortality were observed in 40% (63/159) and 18% (29/159) of the patients, respectively, whereas 35% (57/159) had favorable outcomes (mRS score of 0-2) at discharge. The most common cause of death was pneumonia (62%, 18/29), followed by stroke (28%, 8/29).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
This study is approved by the Japan Stroke Society.
The study is a multi-center, retro-prospective observational study and the study period is between 2020/1/1 and 2022/5/31 but will be finished up to a total of 100 patients who are registered.
Management information
Registered date
| 2020 | Year | 07 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045903
