UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022996 |
|---|---|
| Receipt number | R000026506 |
| Scientific Title | Optimal Medical Therapy Estimated by FDG PET/CT in Myocardial Sarcoidosis |
| Date of disclosure of the study information | 2016/07/04 |
| Last modified on | 2023/07/09 12:01:54 |
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Basic information
Public title
Optimal Medical Therapy Estimated by FDG PET/CT in Myocardial Sarcoidosis
Acronym
Optimal Medical Therapy in Myocardial Sarcoidosis
Scientific Title
Optimal Medical Therapy Estimated by FDG PET/CT in Myocardial Sarcoidosis
Scientific Title:Acronym
Optimal Medical Therapy in Myocardial Sarcoidosis
Region
| Japan |
Condition
Condition
Myocardial sarcoidosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of FDG-PET/CT images in myocardial sarcoidosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of uptaking area estimated by 18F-FDG PET/CT
Key secondary outcomes
Frequency of sudden cardiac death, lethal arrhythmia and heart failure.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
mediacl therapy with methotrexate
Interventions/Control_2
medical therapy with steroid
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Myocardial sarcoidosis
Key exclusion criteria
The patients with
myelosuppression, chronic liver dysfunction, chronic kidney disease and infection.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toyoaki |
| Middle name | |
| Last name | Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Cardiology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-741-2111
murohara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Toyoaki |
| Middle name | |
| Last name | Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Cardiology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-741-2111
Homepage URL
ryota.m0726@med.nagoya-u.ac.jp
Sponsor or person
Institute
The Department of Cardiology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel
052-741-2111
ryota.m0726@med.nagoya-u.ac.jp
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
名古屋大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 04 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026506
