UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041762 |
|---|---|
| Receipt number | R000047408 |
| Scientific Title | A single-center prospective/retrospective registry database of patients with atrial fibrillation aiming to identify clinically applicable biomarkers |
| Date of disclosure of the study information | 2020/09/14 |
| Last modified on | 2020/09/14 13:13:48 |
* 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
A single-center prospective/retrospective registry database of patients with atrial fibrillation aiming to identify clinically applicable biomarkers
Acronym
J-AF registry database (Juntendo-atrial fibrillation registry database)
Scientific Title
A single-center prospective/retrospective registry database of patients with atrial fibrillation aiming to identify clinically applicable biomarkers
Scientific Title:Acronym
J-AF registry database (Juntendo-atrial fibrillation registry database)
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct a prospective/retrospective registry database of patients with atrial fibrillation (AF) in Juntendo University Hospital
Basic objectives2
Others
Basic objectives -Others
To identify clinical factors and clinically applicable biomarkers which associate with the pathogenesis and prognosis of AF
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence of AF within 1-year following catheter ablation
Key secondary outcomes
Ischemic stroke, systemic arterial embolism, cardiovascular death, all-cause mortality within 1-year following catheter ablation
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
Patients with atrial fibrillation undergoing/underwent catheter ablation
Key exclusion criteria
The patients who denied to enroll in this study.
The patients who decided to withdrew from this study.
The patients that one of the our investigators concluded that exclusion from this study is suitable.
Target sample size
2077
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Iwata |
Organization
Juntendo University Hospital
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-3813-3111
h-iwata@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kai |
| Middle name | |
| Last name | Ishii |
Organization
Juntendo University Hospital
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-3813-3111
Homepage URL
ka.ishii@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Department of Cardiovascular Biology and Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo 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
Juntendo Clinical Research and Trial Center
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
+81-3-3814-5672
kenkyu5858@juntendo.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
順天堂大学医学部付属順天堂医院(東京都)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 14 | 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
| 2020 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The prospective part of the study has started on July 30th, 2020. Blood samples are obtained just before the procedure, and at 3, 6, 12 months after the catheter ablation and stocked at -30 degree.
The retrospective part of the study subjects 877 patients who underwent catheter ablation at Juntendo University Hospital from July 1st, 2017 to July 30th, 2020. Clinical information including patients demographics, complications, the status of AF, medications, findings of the electrocardiogram, echocardiography, devices used for catheter ablation, prognosis.
Management information
Registered date
| 2020 | Year | 09 | Month | 11 | Day |
Last modified on
| 2020 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047408
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
