UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053339 |
|---|---|
| Receipt number | R000060882 |
| Scientific Title | Investigation of the relation between myocardial remodeling and glucose metabolism in patients with post myocarditis |
| Date of disclosure of the study information | 2024/01/12 |
| Last modified on | 2024/01/12 19:20:47 |
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Basic information
Public title
Investigation of the relation between myocardial remodeling and glucose metabolism in patients with post myocarditis
Acronym
Investigation of the glucose metabolism in patients with post myocarditis
Scientific Title
Investigation of the relation between myocardial remodeling and glucose metabolism in patients with post myocarditis
Scientific Title:Acronym
FDG uptake post myocarditis
Region
| Japan |
Condition
Condition
Myocarditis
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess abnormalities in myocardial glucose metabolism in the chronic phase of recovery from myocarditis and investigate their association with the degree of recovery of cardiac function and the tendency towards exacerbations.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigate the natural history of cardiac decompensation and heart failure during follow-up.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
History of treatment for acute or suspected myocarditis
Key exclusion criteria
(i) After pacemaker or defibrillator implantation
(ii) Renal dysfunction (estimated GFR <50)
(iii) History of myocardial infarction
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Fukushima |
Organization
Fukushima Medical University
Division name
Department of Radiology and Nuclear Medicine
Zip code
960-1295
Address
Hikariga-oka 1, Fukushima city, Fukushima
TEL
0245471334
kfukush4@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Fukushima |
Organization
Fukushima Medical University
Division name
Department of Radiology and Nuclear Medicine
Zip code
960-1295
Address
Hikariga-oka 1, Fukushima city, Fukushima
TEL
0245471334
Homepage URL
kfukush4@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
Hikariga-oka 1, Fukushima city, Fukushima
Tel
0245471334
fmu@esct.bvits.com
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
| 2024 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 01 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060882
