UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005834
Receipt number R000006895
Scientific Title Registry study of atrial fibrillation patients in Fushimi-ku
Date of disclosure of the study information 2011/06/22
Last modified on 2020/06/28 09:57:03

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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 or person

Institute

National Hospital Organization Kyoto Medical Center

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006895


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name