UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050189 |
|---|---|
| Receipt number | R000057166 |
| Scientific Title | Study of prehospital delay of cerebral infarction from Kochi Acute Stroke Survey of Onset: Association of regional disparities in socioeconomic status and location of stroke hospitals with prehospital delay |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/01/31 14:08:52 |
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Basic information
Public title
Study of prehospital delay of cerebral infarction from Kochi Acute Stroke Survey of Onset
Acronym
Prehospital delay of stroke in Kochi
Scientific Title
Study of prehospital delay of cerebral infarction from Kochi Acute Stroke Survey of Onset: Association of regional disparities in socioeconomic status and location of stroke hospitals with prehospital delay
Scientific Title:Acronym
Prehospital delay of stroke in Kochi with special reference to regional disparities
Region
| Japan |
Condition
Condition
Acute ischemic stroke
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate association between patients' address and prehospital delay
Basic objectives2
Others
Basic objectives -Others
Investigate association between distribution of stroke hospitals around the patient and prehospital delay
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Prehospital delay defined as hospital arrival over 4 hours from the symptom onset
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A patient who were admitted for acute ischemic stroke and whose onset time and arrival time are available
Key exclusion criteria
A patient who were admitted for acute ischemic stroke but their arrival was delayed more than 7 days
Target sample size
9000
Research contact person
Name of lead principal investigator
| 1st name | HITOSHI |
| Middle name | |
| Last name | FUKUDA |
Organization
Kochi University Hospital
Division name
Department of Neurosurgery
Zip code
783-8505
Address
185-1, Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL
088-880-2397
fukudaharpseal@gmail.com
Public contact
Name of contact person
| 1st name | HITOSHI |
| Middle name | |
| Last name | FUKUDA |
Organization
Kochi University Hospital
Division name
Department of Neurosurgery
Zip code
783-8505
Address
185-1, Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL
088-880-2397
Homepage URL
fukudaharpseal@gmail.com
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science, Grant-in-Aid for Scientific Research (C) 21K09127.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi University Hospital, Clinical Research Center
Address
185-1, Kohasu, Oko-cho, Nankoku, Kochi, Japan
Tel
088-880-2140
is21@kochi-u.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
| 2023 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
9000
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057166
