UMIN-CTR Clinical Trial

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

stroke

Classification by specialty

Neurology	Neurosurgery	Emergency medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

k-kimura@nms.ac.jp

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

Email

nomo16@nms.ac.jp

Institute

Nippon Medical School

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

the Japan Stroke Society

Name of secondary funder(s)

Organization

Nippon Medical School IRB

Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo

Tel

0338222131

Email

c-ethics@nms.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

07

Month

27

Day

URL releasing protocol

https://www.sciencedirect.com/science/article/pii/S0022510X23023341

Publication of results

Published

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

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 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.

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