UMIN-CTR Clinical Trial

Basic information
Public title	Automatic detection of acute brain infarction
Acronym	Automatic detection of acute brain infarction
Scientific Title	Automatic detection of acute brain infarction
Scientific Title:Acronym	Automatic detection of acute brain infarction
Region	Japan

Condition
Condition	acute brain infarction
Classification by specialty	Neurology Radiology Neurosurgery Emergency medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To detect abnormal signal intensity on diffusion weighted images of brain MRI by using statistical approach
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of abnormal signal intensity on DWI
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	Patients who underwent brain DWI
Key exclusion criteria	Images with severe artifacts
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Yasutaka Middle name Last name Fushimi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Diagnostic Imaging and Nuclear Medicine
Zip code	6068507
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto JAPAN
TEL	075-751-3760
Email	nmdioffice@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Yasutaka Middle name Last name Fushimi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Diagnostic Imaging and Nuclear Medicine
Zip code	6068607
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto JAPAN
TEL	075-751-3760
Homepage URL
Email	yfushimi@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-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 03 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
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	Open public recruiting
Date of protocol fixation	2018 Year 01 Month 01 Day
Date of IRB	2018 Year 03 Month 27 Day
Anticipated trial start date	2018 Year 03 Month 27 Day
Last follow-up date	2023 Year 03 Month 26 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	2018 Year 01 Month 08 Day
Last modified on	2021 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035076