UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research for myocardial viability by using 18F-FDG PET/MRI
Title of the study (Brief title)	Research for myocardial viability by using 18F-FDG PET/MRI
Region	Japan

Condition
Condition	Old myocardial infarction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the difference among myocardial glucose metabolism, myocardial fibrosis, and ventricular function in the infarcted myocardium.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparizon of myocardial glucose metabolism evaluated by 18F-FDG and myocardial fibrosis evaluated by late gadolinium enhancement.
Key secondary outcomes	Association between presence or absence of myocardial viability and presence or absence of functional improvement.

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	1. Attend to the Fukushima Medical University hospital or are in the hospital. 2. Ischemic heart disease with severe stenosis or occluded coronary artery. 3. Aged 20 year or older. 4. Can provide informed consent.
Key exclusion criteria	1. Patients are unstable condition. 2. Patients are implanted mechanical device. 3. Claustrophobia. 4. Patients who had occurred adverse event with using gadolinium contrast.
Target sample size	100

Research contact person
Name of lead principal investigator	Yasuchika Takeishi
Organization	Fukushima Medical University
Division name	Department of Cardiology and Hematology
Address	1 Hikarigaoka, Fukushima, Japan
TEL	024-547-1190
Email	takeishi@fmu.ac.jp

Public contact
Name of contact person	Atsuro Masuda
Organization	Fukushima Medical University
Division name	Department of Cardiology and Hematology
Address	1 Hikarigaoka, Fukushima, Japan
TEL	024-547-1190
Homepage URL
Email	atsmas@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Fukushima Medical University
Organization
Division
Category of Funding Organization	Self funding
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 03 Month 04 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 17 Day
Anticipated trial start date	2015 Year 12 Month 17 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	Partially published
URL releasing results
Results	Correlation was observed between myocardial glucose metabolism evaluated by PET and myocardial fibrosis evaluated by MRI.
Other related information	Observe relationship among myocardial glucose metabolism, myocardial fibrosis, and changes of ventricular function.

Management information
Registered date	2016 Year 03 Month 04 Day
Last modified on	2018 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024621