UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039818 |
|---|---|
| Receipt number | R000045408 |
| Scientific Title | Prevalence of delayed diagnosis of acute ischaemic stroke in an acute care hospital: a single-centre cross-sectional study in Japan |
| Date of disclosure of the study information | 2020/03/14 |
| Last modified on | 2021/09/02 21:31:13 |
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Basic information
Public title
Prevalence of delayed diagnosis of acute ischaemic stroke in an acute care hospital: a single-centre cross-sectional study in Japan
Acronym
Prevalence of delayed diagnosis of acute ischaemic stroke in an acute care hospital
Scientific Title
Prevalence of delayed diagnosis of acute ischaemic stroke in an acute care hospital: a single-centre cross-sectional study in Japan
Scientific Title:Acronym
Prevalence of delayed diagnosis of acute ischaemic stroke
Region
| Japan |
Condition
Condition
acute Ischaemic stroke
Classification by specialty
| Medicine in general | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence of missed ischaemic stroke diagnoses at initial contact.
Basic objectives2
Others
Basic objectives -Others
To investigate the prevalence of potentially treatable patients without a delayed diagnosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was a delayed diagnosis of ischaemic stroke at initial contact.
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All hospitalised patients due to acute ischaemic stroke confirmed by magnetic resonance imaging.
Key exclusion criteria
Patients who were suspected to have or diagnosed with ischaemic stroke at other hospitals were excluded.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | Komagamine |
| Last name | Komagamine |
Organization
National Hospital Organization Tochigi Medical Center
Division name
Department of Internal Medicine
Zip code
3208580
Address
1-10-37, Nakatomatsuri
TEL
0286225241
jkomagamine@tochigi-mc.jp
Public contact
Name of contact person
| 1st name | Junpei |
| Middle name | Komagamine |
| Last name | Komagamine |
Organization
National Hospital Organization Tochigi Medical Center
Division name
Department of Internal Medicine
Zip code
3208580
Address
1-10-37, Nakatomatsuri
TEL
0286225241
Homepage URL
jkomagamine@tochigi-mc.jp
Sponsor or person
Institute
National Hospital Organization Tochigi Medical Center
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethical Committee of the National Hospital Organization Tochigi Medical Center
Address
1-10-37, Nakatomatsuri
Tel
0286225241
atamura@tochigi-mc.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 | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1002/jgf2.440
Number of participants that the trial has enrolled
408
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective and prospective single-centre cross-sectional study using electronic medical record will be conducted. More than 400 consecutive patients hospitalised due to acute ischaemic stroke since April 2017. The primary outcome was a delayed diagnosis of ischaemic stroke at initial contact. A diagnosis of stroke was judged to be delayed unless physicians made a diagnosis and initiated treatment for ischaemic stroke during the initial contact. The secondary outcome was ischaemic stroke with a missed therapeutic window for effective treatments due to delayed diagnosis.
Management information
Registered date
| 2020 | Year | 03 | Month | 14 | Day |
Last modified on
| 2021 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045408
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
