UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The diagnostic value of myocardial T1 mapping
Title of the study (Brief title)	Myocardial T1 mapping
Region	Japan

Condition
Condition	Cradiomyopathy
Classification by specialty	Cardiology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the diagnostic value of T1 mapping obtained SMART1map.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Detection of pathological myocardial tissue by T1 mapping
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A person who has a cardiac MRI examination with an agreement to be enrolled in this study after obtaining informed consent
Key exclusion criteria	1. A person who is less than 20 years old 2. A person who is pregnant or suspected to be pregnant 3. A person who has any implant functioning electrically, magnetically or mechanically 4. Claustrophobia 5. Contraindication for the use of Gadolinium-based contrast material
Target sample size	30

Research contact person
Name of lead principal investigator	Shigeo Okuda
Organization	Keio University School of Medicine
Division name	Department of Diagnostic Radiology
Address	Shinanomachi 35, Shinjyuku-ku, Tokyo, JAPAN
TEL	03-3225-5715
Email	shige@keio.jp

Public contact
Name of contact person	Shigeo Okuda
Organization	Keio University School of Medicine
Division name	Department of Diagnostic Radiology
Address	Shinanomachi 35, Shinjyuku-ku, Tokyo, JAPAN
TEL	03-3225-5715
Homepage URL
Email	shige@keio.jp

Sponsor
Institute	Department of Diagnostic Radiology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Profit organization
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	慶應義塾大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 13 Day
Anticipated trial start date	2015 Year 01 Month 10 Day
Last follow-up date	2016 Year 10 Month 22 Day
Date of closure to data entry	2016 Year 10 Month 22 Day
Date trial data considered complete	2016 Year 10 Month 22 Day
Date analysis concluded	2016 Year 10 Month 24 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Using the cross-sectional method in which T1 map will be compared to LGE obtained in the same examination

Management information
Registered date	2015 Year 01 Month 07 Day
Last modified on	2016 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018751