UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026782 |
|---|---|
| Receipt number | R000030657 |
| Scientific Title | Relationship between corticosteroid therapy for cardiac sarcoidosis and ventricular arrhythmia |
| Date of disclosure of the study information | 2017/04/03 |
| Last modified on | 2022/04/03 10:00:47 |
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Basic information
Public title
Relationship between corticosteroid therapy for cardiac sarcoidosis and ventricular arrhythmia
Acronym
Relationship between corticosteroid therapy for cardiac sarcoidosis and ventricular arrhythmia
Scientific Title
Relationship between corticosteroid therapy for cardiac sarcoidosis and ventricular arrhythmia
Scientific Title:Acronym
Relationship between corticosteroid therapy for cardiac sarcoidosis and ventricular arrhythmia
Region
| Japan |
Condition
Condition
Cardiac sarcoidosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of corticosteroid therapy on ventricular arrhythmia.
Basic objectives2
Others
Basic objectives -Others
Also, to clarify the relationship between ventricular arrhythmia and FDG-PET uptake.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ventricular arrhythmia,including ventricular fibrillation/tachycardia and ventricular premature contraction by 24h-Holter ECG at day3,7,21 after initiation of steroid therapy.
Cardiac FDG-PET uptake before and after(1-2month) introduction of steroid therapy.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed with cardiac sarcoidosis and scheduled to undergo corticosteroid therapy.
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Takamura |
Organization
Kanazawa University Graduate School of Advanced Preventive Medical Sciences
Division name
Department of System Biology
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2000
mtakamura@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunichiro Hondo |
Organization
Graduate School of Advanced Preventive Medical Sciences
Division name
Department of System Biology
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2000
Homepage URL
shunichiro.h.27@gmail.com
Sponsor or person
Institute
Kanazawa University
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
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
| 2017 | Year | 04 | Month | 03 | 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 | 12 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
We register patients who are diagnosed with cardiac sarcoidosis and scheduled to undergo corticosteroid therapy.
The objective of this study is to clarify the relationship between the severity of cardiac inflammation and ventricular arrhythmia after initiation steroid therapy.
We evaluate ventricular arrhythmia,including ventricular fibrillation/tachycardia and ventricular premature contraction by 24h-Holter ECG at day3,7,21 after initiation of steroid therapy.
Also, we perform cardiac FDG-PET uptake before and after(1-2month) introduction of steroid therapy.
Management information
Registered date
| 2017 | Year | 03 | Month | 30 | Day |
Last modified on
| 2022 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030657
