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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021351
Receipt No. R000024621
Scientific Title Research for myocardial viability by using 18F-FDG PET/MRI
Date of disclosure of the study information 2016/03/04
Last modified on 2018/12/22

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Basic information
Public title Research for myocardial viability by using 18F-FDG PET/MRI
Acronym Research for myocardial viability by using 18F-FDG PET/MRI
Scientific Title Research for myocardial viability by using 18F-FDG PET/MRI
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuchika Takeishi
Organization Fukushima Medical University
Division name Department of Cardiology and Hematology
Zip code
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1190
Email takeishi@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuro Masuda
Organization Fukushima Medical University
Division name Department of Cardiology and Hematology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Correlation was observed between myocardial glucose metabolism evaluated by PET and myocardial fibrosis evaluated by MRI.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2015 Year 12 Month 17 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000024621

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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