UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050841 |
|---|---|
| Receipt number | R000057921 |
| Scientific Title | Follow up study of patients undergoing catheter ablation for atrial fibrillation:evaluation of long-term outcomes and predictive factors based on genetic predisposition-subgroup analysis in patients with atrial biopsy and proteomics |
| Date of disclosure of the study information | 2023/04/13 |
| Last modified on | 2023/04/13 22:05:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Follow up study of patients undergoing catheter ablation for atrial fibrillation:evaluation of long-term outcomes and predictive factors based on genetic predisposition-subgroup analysis in patients with atrial biopsy and proteomics
Acronym
FUTURE-AF-S Study
Scientific Title
Follow up study of patients undergoing catheter ablation for atrial fibrillation:evaluation of long-term outcomes and predictive factors based on genetic predisposition-subgroup analysis in patients with atrial biopsy and proteomics
Scientific Title:Acronym
FUTURE-AF-S Study
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate whether genetic markers or genetic risk scores for atrial fibrillation predict the incidence of cardiovascular events and recurrence of atrial fibrillation at 36 months after atrial fibrillation ablation in a Japanese population
Basic objectives2
Others
Basic objectives -Others
To identify which proteins (groups) are significant biomarkers for the progression of atrial fibrillation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Association of genetic markers or genetic risk scores with histological findings and proteomic data
Key secondary outcomes
Association of histological findings with proteomic data
Association of histological findings with transcriptomic data
Association of proteomic data with transcriptomic data
Association of histological findings with 3-year post-ablation outcomes
Association of proteomic data with 3-year post-ablation outcomes
Association of transcriptomic data with 3-year post-ablation outcomes
Association of histological findings with cardiovascular events
Association of proteomic data with cardiovascular events
Association of transcriptomic data with cardiovascular events
Association of histological findings with atrial tachyarrhythmia recurrence
Association of proteomic data with atrial tachyarrhythmia recurrence
Association of transcriptomic data with atrial tachyarrhythmia recurrence
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients who have agreed to participate in the FUTURE-AF study
(2)Patients who undergo radiofrequency catheter ablation for atrial fibrillation during the period from the approval of the ethical review of clinical research to December 31, 2026.
(3)Age 18 years or older
Key exclusion criteria
(1)Patients who are judged by the attending physician to be unsuitable for participation in the study
(2)Patients who have expressed their non-participation in the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | TAKANORI |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Saga University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1Nabeshima,Saga
TEL
0952342443
takanori@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKANORI |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Saga University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1Nabeshima,Saga
TEL
0952342443
Homepage URL
takanori@cc.saga-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Saga University
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Saga University
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
CLINICAL RESEARCH CENTER,SAGA UNIVERSITY HOSPITAL
Address
5-1-1Nabeshima,Saga
Tel
0952343400
kenkyu-shinsei@ml.cc.saga-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
大分大学医学部循環器内科・臨床検査診断学講座（大分）
東京大学医学部附属病院循環器内科（東京）
理化学研究所生命医科学研究センター（神奈川）
国立長寿医療研究センターメディカルゲノムセンター（愛知）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 13 | 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
| 2022 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2032 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation Details
Recurrence of atrial tachyarrhythmias and the type of arrhythmia during the 36-month post-ablation period
Cardiovascular events during the 36-month post-ablation period
Management information
Registered date
| 2023 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057921
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
