UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of values of myocardial T1 and T2 mapping
Title of the study (Brief title)	Values of myocardial T1 and T2 mapping
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the clinical values of T1 and T2 mapping
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Myocardial T1 and T2 values
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Measurement of myocaridial T1 and T2
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	The subject are patients who visited Keio University Hospital and whose cardiac MRI was ordered for evaluating cardiac disease. In addition, the written informed consent is indispensable for enrolling in this study.
Key exclusion criteria	1. Patients who is younger than 20 y/o 2. Patients during pregnancy or with suspicion of pregnancy 3. Patient who have implants which operate electrically, magnetically or mechanically (e.g. pacemaker) 4. Claustrophobia
Target sample size	100

Research contact person
Name of lead principal investigator	Shigeo Okuda
Organization	Keio University School of Medicine
Division name	Department of Diagnostic Radiology
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL	03-3353-1211
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	35 Shinanomachi, Shinjyuku-ku, Tokyo Japan
TEL	03-3353-1211
Homepage URL
Email	shige@keio.jp

Sponsor
Institute	Keio University School of Medicine Department of Diagnostic Radiology
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	2016 Year 09 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 14 Day
Anticipated trial start date	2016 Year 09 Month 12 Day
Last follow-up date
Date of closure to data entry	2018 Year 01 Month 01 Day
Date trial data considered complete	2018 Year 03 Month 01 Day
Date analysis concluded	2018 Year 07 Month 01 Day

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Publication of results	Unpublished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

Management information
Registered date	2016 Year 09 Month 05 Day
Last modified on	2018 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027557