UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051130 |
|---|---|
| Receipt number | R000058311 |
| Scientific Title | ALDH2 based genetically tailored management following catheter ablation for atrial fibrillation |
| Date of disclosure of the study information | 2023/05/23 |
| Last modified on | 2023/05/23 16:55:01 |
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Basic information
Public title
ALDH2 based genetically tailored management following catheter ablation for atrial fibrillation
Acronym
AGENT-AF
Scientific Title
ALDH2 based genetically tailored management following catheter ablation for atrial fibrillation
Scientific Title:Acronym
AGENT-AF
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The porpose of this study is to demonstrate the risk reduction of atrial fibrillation recurrence following catheter ablation by alcohol abstinence, based on the ALDH2 genetic information in multicenter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference in atrial fibrillation recurrence during one year follow up following catheter ablation between the group with and without alcohol control guidance. This investigation was performed in each ALDH2 gene.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patients with a drinking habit in ALDH2 wild type carriers who do not receive drinking guidance (period of 1 year).
Interventions/Control_2
Patients with a drinking habit among ALDH2 wild type carriers who will receive drinking guidance (period of one year).
Interventions/Control_3
Patients with a drinking habit in ALDH2 variant carriers who do not receive drinking guidance (period of 1 year).
Interventions/Control_4
Patients with a drinking habit among ALDH2 variant carriers who will receive drinking guidance (period of one year).
Interventions/Control_5
Patients without a habitual alcohol consumption among ALDH2 wild carrier.
Interventions/Control_6
Patients without a habitual alcohol consumption among ALDH2 variant carrier.
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 undergoing initial catheter ablation for atrial fibrillation at participating institutions.
Key exclusion criteria
Exclude definition is refuse of the target patient.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Hoshiyama |
Organization
Kumamoto University Hospital
Division name
Cardiovascular medicine
Zip code
860-8556
Address
1-1-1 honjo Kumamoto City
TEL
096-373-5175
tadashi@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Hoshiyama |
Organization
Kumamoto University
Division name
Cardiovascular medicine
Zip code
860-8556
Address
1-1-1 honjo Kumamoto city
TEL
096-373-5175
Homepage URL
tadashi@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
JPSS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University Hospital
Address
1-1-1 honjo Kumamoto city
Tel
096-373-5657
ski-shien@jimu.kumamoto-u.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
| 2023 | Year | 05 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2023 | Year | 05 | Month | 22 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058311
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| Registered date | File name |
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