UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021351 |
|---|---|
| Receipt number | 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 11:06:28 |
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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
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
atsmas@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024621
