UMIN-CTR Clinical Trial

Basic information
Public title	Registry study of atrial fibrillation patients in Fushimi-ku
Acronym	Fushimi AF Registry
Scientific Title	Registry study of atrial fibrillation patients in Fushimi-ku
Scientific Title:Acronym	Fushimi AF Registry
Region	Japan

Condition
Condition	atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the present status of treatment and management of Japanese patients with atrial fibrillation in Fushimi-ku (southern area of Kyoto city).
Basic objectives2	Others
Basic objectives -Others	Registration and follow-up
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	stroke or systemic embolism
Key secondary outcomes	all cause death, cardiac death, hospitalization due to heart failure, myocardial infarction, hemorrhage, bradyarrhythmic events, tachyarrhythmic events, drug side effects.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with atrial fibrillation documented on electrocardiography
Key exclusion criteria	none
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Masaharu Middle name Last name Akao
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Cardiology
Zip code	612-8555
Address	Kyoto
TEL	0756419161
Email	akao@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Masaharu Middle name Last name Akao
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Cardiology
Zip code	612-8555
Address	1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL	075-641-9161
Homepage URL	https://edmsweb16.eps.co.jp/edmsweb/002001/FAF/top.html
Email	fushimi.af@gmail.com

Sponsor
Institute	National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Kyoto Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization Kyoto Medical Center
Address	1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
Tel	0756419161
Email	akao@kuhp.kyoto-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	国立病院機構京都医療センター（京都府）、医仁会武田総合病院（京都府）、伏見区医師会（京都府）

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 22 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	5000
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	2010 Year 10 Month 18 Day
Date of IRB	2010 Year 10 Month 18 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prevalence of anticoagulation drugs in Japanese AF patients in Fushimi-ku.

Management information
Registered date	2011 Year 06 Month 22 Day
Last modified on	2020 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006895