UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of subclavian artery visualization in non-contrast asynchronous MR Angiography
Title of the study (Brief title)	Investigation of subclavian artery visualization in non-contrast asynchronous MR Angiography
Region	Japan

Condition
Condition	Subclavian artery stenosis
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	REACT (Reaction (React) (Relaxation Enhanced Angiography without Contrast & Triggering), which is a novel technique for obtaining a clear image of a blood vessel without using a contrast medium and furthermore without having to adjust the timing to the patient's breathing and heartbeat By using it we decided to engage in research to verify the possibility that the burden on the patient is small and clear images can be obtained.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual evaluation Signal value change
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	expanded access
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment Other
Interventions/Control_1	Intervention test on MRI examination
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	25 years-old <=
Age-upper limit	50 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy person
Key exclusion criteria	People without medical history
Target sample size	20

Research contact person
Name of lead principal investigator	yuka hirose
Organization	National Hospital Organization Kyushu Medical Center
Division name	Radiation section
Address	8th No.1, Chuo-ku, Fukuoka city
TEL	092-852-0700
Email	yuka.h0805@gmail.com

Public contact
Name of contact person	yuka hirose
Organization	National Hospital Organization Kyushu Medical Center
Division name	Radiation section
Address	8th No.1, Chuo-ku, Fukuoka city
TEL	092-852-0700
Homepage URL
Email	yuka.h0805@gmail.com

Sponsor
Institute	National Hospital Organization Kyushu Medical Center (Clinical Research Center)
Institute
Department

Funding Source
Organization	National Hospital Organization Kyushu Medical Center (Clinical Research Center)
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	yhirose-fkok
Org. issuing International ID_1	20190122-185037
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 02 Month 13 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 10 Month 30 Day
Anticipated trial start date	2018 Year 10 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 01 Month 30 Day
Last modified on	2019 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040641