UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Aproach to optimize the dose of contrasut medicum considering patient's blood flow on CTA.
Title of the study (Brief title)	contrast medium on CTA
Region	Japan

Condition
Condition	none
Classification by specialty	Medicine in general Surgery in general Vascular surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To optimize contrast medium on CTA
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CT value of aorta
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Method of injection of contrast medium
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	Patient of CTA scan
Key exclusion criteria	1.Case of constraction of the adamkiewicz artery 2.Case of ECG gating 3.Case of deteriorated images due to fail in hold bless 4.Case of emergence
Target sample size	50

Research contact person
Name of lead principal investigator	Yohei Sugita
Organization	Ryukyu unversity hospital
Division name	Radiation part
Address	207,uehara,nishihara,nakakamigun,okinawa
TEL	0988953331
Email	oh.september.13@gmail.com

Public contact
Name of contact person	Yohei Sugita
Organization	Ryukyu unversity hospital
Division name	Radiation part
Address	207,uehara,nishihara,nakakamigun,okinawa
TEL	0988953331
Homepage URL
Email	oh.september.13@gmail.com

Sponsor
Institute	Ryukyu unversity hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2017 Year 07 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 01 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	2017 Year 04 Month 18 Day
Last modified on	2017 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031004