UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048952 |
|---|---|
| Receipt number | R000055777 |
| Scientific Title | JApanese Cardiac Sarcoidosis Registry (JACS Registry) |
| Date of disclosure of the study information | 2022/09/16 |
| Last modified on | 2023/03/23 19:14:50 |
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Basic information
Public title
JApanese Cardiac Sarcoidosis Registry (JACS Registry)
Acronym
JACS Registry
Scientific Title
JApanese Cardiac Sarcoidosis Registry (JACS Registry)
Scientific Title:Acronym
JACS Registry
Region
| Japan |
Condition
Condition
Cardiac sarcoidosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will create a large national registry of the incidence, prognosis and treatment of fatal arrhythmias in cardiac sarcoidosis at this time, and will examine the problems with corticosteroid therapy and establish a new treatment system for cardiac sarcoidosis, including the position of non-pharmacological therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of composite endpoint (cardiovascular death or fatal arrhythmia or heart failure hospitalization)
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
All patients diagnosed with cardiac sarcoidosis
Key exclusion criteria
1) It is a registry and there are no specific exclusion criteria.
2) Patients who refused to participate in the study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kusano |
| Middle name | |
| Last name | Kengo |
Organization
Natonal cerebral and cardiovascular center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibeshimmachi, Suita, Oska, Japan
TEL
06-6170-1070
kusanokengo@hotmail.com.
Public contact
Name of contact person
| 1st name | Ishibashi |
| Middle name | |
| Last name | Kohei |
Organization
Natonal cerebral and cardiovascular center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibeshimmachi, Suita, Oska, Japan
TEL
06-6170-1070
Homepage URL
kohei-ishibashi@ncvc.go.jp
Sponsor or person
Institute
Natonal cerebral and cardiovascular center
Institute
Department
Personal name
Funding Source
Organization
Natonal cerebral and cardiovascular center
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
Natonal cerebral and cardiovascular center
Address
6-1 Kishibeshimmachi, Suita, Oska, Japan
Tel
06-6170-1070
rec-office-ac@ncvc.go.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 16 | 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
| 2020 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none in particular
Management information
Registered date
| 2022 | Year | 09 | Month | 16 | Day |
Last modified on
| 2023 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055777
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
