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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036784
Receipt No. 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

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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
Email 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
Email kojisoccer2002@yahoo.co.jp

Sponsor
Institute kobe university graduate school of medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019127

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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