UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036784 |
|---|---|
| Receipt number | R000019127 |
| Scientific Title | Prognosis about stroke, systemic embolism, or dementia in patients with atrial fibrillation treated with and without ablation. |
| Date of disclosure of the study information | 2019/05/17 |
| Last modified on | 2019/05/17 16:05:41 |
* 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
Prognosis about stroke, systemic embolism, or dementia in patients with atrial fibrillation treated with and without ablation.
Acronym
Hyogo AF network
(HAF-Net)
Scientific Title
Prognosis about stroke, systemic embolism, or dementia in patients with atrial fibrillation treated with and without ablation.
Scientific Title:Acronym
Hyogo AF network
(HAF-Net)
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Hyogo AF network is a prospective investigation in Hyogo prefecture in order to evaluate the prognosis about stroke, systemic embolism, or dementia in patients with atrial fibrillation treated with and without ablation.
Basic objectives2
Others
Basic objectives -Others
Registration and follow-up
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
stroke(including transient ischemic attack), systemic embolism, or major hemorrhage
Key secondary outcomes
dementia, cardiac hospitalization, and all cause death
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 documented on 12 lead electrocardiography
Key exclusion criteria
none
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Yoshida |
Organization
Kita-Hrima Medical Center
Division name
Department of Cardiology
Zip code
675-1392
Address
926-250 Ichiba-cho, Ono city, Hyogo
TEL
0794-88-8800
ayoshida@kitahari-mc.jp
Public contact
Name of contact person
| 1st name | Kojiro |
| Middle name | |
| Last name | Fukuzawa |
Organization
kobe university graduate school of medicine
Division name
division of cardiovascular medicine, department of internal medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuou-ku, Kobe
TEL
078-382-5846
Homepage URL
kojisoccer2002@yahoo.co.jp
Sponsor or person
Institute
kobe university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
kobe university graduate school of medicine
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
The Ethics Committee at Kobe university graduate school of medicine
Address
7-5-2 Kusunoki-cho, Chuou-ku, Kobe
Tel
078-382-6669
kansatsu@med.kobe-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
| 2019 | Year | 05 | Month | 17 | 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
2168
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
clinical outcome of patients with atrial fibrillation in Hyogo prefecture.
Management information
Registered date
| 2019 | Year | 05 | Month | 17 | Day |
Last modified on
| 2019 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019127
