UMIN-CTR Clinical Trial

Basic information
Public title	Classifying aortic dissection based on computed topography using a machine learning approach
Acronym	Machine learning application for aortic dissection
Scientific Title	Machine learning application for aortic dissection
Scientific Title:Acronym	Machine learning application for aortic dissection
Region	Japan

Condition
Condition	aortic dissection
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to classify patients with aortic dissection and those without applying a machine learning approach for CT images.
Basic objectives2	Others
Basic objectives -Others	classification
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	diagnosis of aortic dissection
Key secondary outcomes	pathophysiology of aortic dissection

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	100 years-old >
Gender	Male and Female
Key inclusion criteria	People who visited Chibanishi General Hospital with suspicion of having aortic dissection and underwent CT scan
Key exclusion criteria	none
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Ito Middle name Last name Yujiro
Organization	Chibanishi general hospital
Division name	Dept. Cardiovascular surgery
Zip code	270-2251
Address	1-107 Kanegasaku Matsudo, Chiba
TEL	047-384-8111
Email	yujiroito@hotmail.com

Public contact
Name of contact person	1st name Aoki Middle name Y Last name Yuta
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Zip code	157-8577
Address	6-11-11 Kitakarasuyama Setagaya, Tokyo, Japan
TEL	03-5315-9357
Homepage URL
Email	yuaoki-tky@umin.ac.jp

Sponsor
Institute	Chibanishi general hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	MIDDR at Showa University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Chibanishi general hospital
Address	1-107 Kanegasaki Matsudo, Chiba
Tel	047-384-8111
Email	yujiroito@hotmail.com

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 10 Month 31 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 12 Month 15 Day
Date of IRB	2019 Year 10 Month 23 Day
Anticipated trial start date	2019 Year 12 Month 15 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2019 Year 10 Month 30 Day
Last modified on	2020 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043270