UMIN-CTR Clinical Trial

Basic information
Public title	Influence of using a supporting system for acute stroke on the treatment times
Acronym	Influence of using a supporting system for acute stroke on the treatment times
Scientific Title	Prospective multicenter observational study to confirm the influence of using a supporting system for acute stroke care on the effect of treatment times for stroke care
Scientific Title:Acronym	Prospective multicenter observational study to confirm the influence of using a supporting system for acute stroke care on the effect of treatment times for stroke care
Region	Japan

Condition
Condition	Acute ischemic stroke
Classification by specialty	Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect of a supporting system for acute stroke care on shortening treatment times
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Door to Neede time
Key secondary outcomes	Door to CT time Door to CBC time Door to puncture time mRS at disturge mRS at thee month

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Acute ischemic stroke patients
Key exclusion criteria	Refused to participate in this study
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Shoji Middle name Last name Matsumoto
Organization	Fujita Health University School of Medicine
Division name	Department of Comprehensive Strokology
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL	0562939759
Email	shoji.neuro@gmail.com

Public contact
Name of contact person	1st name Shoji Middle name Last name Matsumoto
Organization	Fujita Health University School of Medicine
Division name	Department of Comprehensive Strokology
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL	0562939759
Homepage URL
Email	shoji.neuro@gmail.com

Sponsor
Institute	Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	This work was supported by a Grant-in-Aid for Scientific Research (16K10727).
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	Fujita Health University School of Medicine
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
Tel	0562932865
Email	f-irb@fujita-hu.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	2019 Year 06 Month 18 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	Enrolling by invitation
Date of protocol fixation	2019 Year 04 Month 19 Day
Date of IRB	2018 Year 10 Month 18 Day
Anticipated trial start date	2019 Year 06 Month 18 Day
Last follow-up date	2021 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2021 Year 06 Month 18 Day
Date analysis concluded

Other

Other related information

Opt-out consent was obtained instead of written informed consent, which was approved by the Ethics Committee of Fujita Health University School of Medicine. We provided patients with information explaining the proposed research plan (the purpose, required individual data, and duration of the study) via the website of Fujita Health University School of Medicine, and gave them the opportunity to opt out.

Management information
Registered date	2019 Year 06 Month 17 Day
Last modified on	2021 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042256