UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036281 |
|---|---|
| Receipt number | R000041324 |
| Scientific Title | Prospective study of the patients with cardiac sarcoidosis |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2024/08/10 09:16:06 |
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Basic information
Public title
Prospective study of the patients with cardiac sarcoidosis
Acronym
Prospective study of the patients with cardiac sarcoidosis
Scientific Title
Prospective study of the patients with cardiac sarcoidosis
Scientific Title:Acronym
Prospective study of the patients with cardiac sarcoidosis
Region
| Japan |
Condition
Condition
Cardiac Sarcoidosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospective observational study of the patients with cardiac sarcoidosis for 5 years
Basic objectives2
Others
Basic objectives -Others
Prospective observational study of the patients with cardiac sarcoidosis for 5 years
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
all-cause death
Key secondary outcomes
non-fatal myocardial infarction, non-fatal stroke, fatal arrhythmia, and admission due to congestive heart failure
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20 Years and older
2) Those who are willing to cooperate with us in the study
3) Those who can sign the informed consent document that is approved by the ethics committee of the medical institution participating in the study
Key exclusion criteria
1) Those who the physician in charge judges are ineligible for the study due to serious pathological conditions
2) Those who are not willing to participate in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Kawai |
Organization
Fujita Health University
Division name
Department of Cardiology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-2312
hkawai@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kawai |
Organization
Fujita Health University
Division name
Department of Cardiology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-2312
Homepage URL
hkawai@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2019 | Year | 03 | Month | 24 | Day |
Last modified on
| 2024 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041324
