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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022996
Receipt No. 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 2019/07/06

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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
Middle name
Last name Toyoaki Murohara
Organization Nagoya University Graduate School of Medicine
Division name Cardiology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-741-2111
Email murohara@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryota Morimoto
Organization Nagoya University Graduate School of Medicine
Division name Cardiology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-741-2111
Homepage URL
Email ryota.m0726@med.nagoya-u.ac.jp

Sponsor
Institute The Department of Cardiology, Nagoya University Graduate School of Medicine
Institute
Department

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
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 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 Open public recruiting
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

Other
Other related information

Management information
Registered date
2016 Year 07 Month 03 Day
Last modified on
2019 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026506

Research Plan
Registered date File name
2017/02/13 別記様式第2号の4 研究計画書 sarcoidosis 9-5.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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