UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051724 |
|---|---|
| Receipt number | R000058502 |
| Scientific Title | A nationwide clinical survey on diagnosis, treatment, and prognosis of patients with fatal ventricular arrhythmias using the JROAD-DPC database. Research C: Brugada Syndrome. |
| Date of disclosure of the study information | 2023/07/27 |
| Last modified on | 2023/07/27 10:52:47 |
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Basic information
Public title
A nationwide clinical survey on diagnosis, treatment, and prognosis of patients with Brugada syndrome using the JROAD-DPC database.
Acronym
JROAD-Brugada Study
Scientific Title
A nationwide clinical survey on diagnosis, treatment, and prognosis of patients with fatal ventricular arrhythmias using the JROAD-DPC database.
Research C: Brugada Syndrome.
Scientific Title:Acronym
JROAD-Brugada Study
Region
| Japan |
Condition
Condition
Brugada syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the diagnosis, treatment, and outcomes of patients with Brugada syndrome.
Basic objectives2
Others
Basic objectives -Others
To clarify sexual differences in the diagnosis, treatment, and outcomes of patients with Brugada syndrome.
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
All cause death
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
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, Diagnosis of "Brugada syndrome"
2, Admission between April 1, 2016, and March 31, 2021
Key exclusion criteria
1. Patients who wished to be excluded from the study
2. Records with insufficient information
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Aiba |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
No.6-1, Kishibe-Shimmachi, Suita, Osaka, Japan
TEL
06-6170-1070
jroad_brugada@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Aiba |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
No.6-1, Kishibe-shimmachi, Suita, Osaka, Japan
TEL
06-6170-1070
Homepage URL
jroad_brugada@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
No.6-1, Kishibe-shimmachi, Suita, Osaka, Japan
Tel
06-6170-1070
jroad_brugadaATncvc.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
| 2023 | Year | 07 | Month | 27 | 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
| 2023 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2023 | Year | 07 | Month | 27 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058502
| 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 |
