UMIN-CTR Clinical Trial

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
Email	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/
Email	kiihara@ns.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039936