UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035022 |
|---|---|
| Receipt number | R000039936 |
| Scientific Title | Influence of prehospital delay and facility capability on the clinical outcomes of acute ischemic stroke |
| Date of disclosure of the study information | 2018/11/28 |
| Last modified on | 2019/12/25 20:09:21 |
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Basic information
Public title
Influence of prehospital delay and facility capability on the clinical outcomes of acute ischemic stroke
Acronym
J-ASPECT transport
Scientific Title
Influence of prehospital delay and facility capability on the clinical outcomes of acute ischemic stroke
Scientific Title:Acronym
J-ASPECT transport
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Emergency medical services (EMS) and inpatient stroke databases and sought to examine whether total EMS transport time and facility capability of stroke care are associated with outcomes in patients with Acute Ischemic Stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30 day mortality after the hospitalaization for stroke and modified Rankin Scale 0-2
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
| 1 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We identified patients hospitalized for stroke in a deidentified discharge database using the International Classification of Diseases (ICD)10 diagnosis codes related to ischemic stroke (I63 0to9), nontraumatic intracerebral haemorrhage (ICH I61 0 to9) and subarachnoid haemorrhage (SAH I60 0to9). Because of major differences in their typical prognosis, patients with transient ischemic attack were excluded. We further selected those patients who had been urgently admitted between 1 April 2013 and 31 March 2015 to the hospitals.
Key exclusion criteria
Non emergent cases
Target sample size
53858
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Iihara |
Organization
Kyushu University, Graduate School of Medical Sciences
Division name
Department of Neurosurgery
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka,, Japan
TEL
+81-92-642-5521
kiihara@ns.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Iihara |
Organization
Kyushu University, Graduate School of Medical Sciences
Division name
Department of Neurosurgery
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL
+81-92-642-5521
Homepage URL
https://j-aspect.jp/
kiihara@ns.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
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
Kyushu University
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka,, Japan
Tel
+81-92-642-5521
kiihara@ns.med.kyushu-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
| 2018 | Year | 11 | Month | 28 | 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
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
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A total of 53,858 patients with AIS were included in the final analyses.
Management information
Registered date
| 2018 | Year | 11 | Month | 27 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039936
