UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020096
Receipt number R000023214
Scientific Title Multicenter Registry Study to Identify the Frequency of Undetected Atrial Fibrillation in Actual Clinical Practice (REAL AF study)
Date of disclosure of the study information 2015/12/08
Last modified on 2019/04/01 16:08:50

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Basic information

Public title

Multicenter Registry Study to Identify the Frequency of Undetected Atrial Fibrillation in Actual Clinical Practice
(REAL AF study)

Acronym

Multicenter Registry Study to Identify the Frequency of Undetected Atrial Fibrillation in Actual Clinical Practice
(REAL AF study)

Scientific Title

Multicenter Registry Study to Identify the Frequency of Undetected Atrial Fibrillation in Actual Clinical Practice
(REAL AF study)

Scientific Title:Acronym

Multicenter Registry Study to Identify the Frequency of Undetected Atrial Fibrillation in Actual Clinical Practice
(REAL AF study)

Region

Japan


Condition

Condition

1.Heart failure/left ventricular
dysfunction*
2.Hypertension
3.Diabetes mellitus
4.Vascular disease (myocardial infarction, past history of angina pectoris, peripheral artery disease, and aortic plaque)
5.Past history of cerebral infarction/transient ischemic attack (TIA)
6.Cardiomyopathy (hypertrophic, dilated, restrictive, arrhythmogenic right ventricular cardiomyopathy, and unclassifiable)
* Refers to the case where the left ventricular ejection fraction is less than 40%.

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1.To reveal the actual frequency of outpatients with atrial fibrillation, including asymptomatic atrial fibrillation, in Japan.
2.To reveal the presence or absence of anticoagulation therapy when detecting one atrial fibrillation.

Basic objectives2

Others

Basic objectives -Others

1.To reveal the actual frequency of outpatients with atrial fibrillation, including asymptomatic atrial fibrillation, in Japan.
2.To reveal the presence or absence of anticoagulation therapy when detecting one atrial fibrillation.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To reveal the actual frequency of outpatients with atrial fibrillation, including asymptomatic atrial fibrillation, in Japan.

Key secondary outcomes

To reveal the presence or absence of anticoagulation therapy when detecting one atrial fibrillation.


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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Outpatients aged 65 years or older without a past history of atrial fibrillation who have at least 1 of the following factors:
1.Heart failure/left ventricular
dysfunction*
2.Hypertension
3.Diabetes mellitus
4.Vascular disease (myocardial infarction, past history of angina pectoris, peripheral artery disease, and aortic plaque)
5.Past history of cerebral infarction/transient ischemic attack (TIA)
6.Cardiomyopathy (hypertrophic, dilated, restrictive, arrhythmogenic right ventricular cardiomyopathy, and unclassifiable)
* Refers to the case where the left ventricular ejection fraction is less than 40%.

Key exclusion criteria

1.History of atrial fibrillation
2.Patients in whom thromboembolism or myocardial infarction has developed within 2 months before registration
3.Patients who have undergone implantation of pacemakers, implantable defibrillators, biventricular pacemakers, implantable defibrillators with biventricular pacing function, and loop recorders
4.Patients who have undergone prosthetic valve replacement
5.Pregnant women, lactating women, and women who may possibly be pregnant
6.Other patients judged inappropriate by the principal investigator or subinvestigator

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Yasuo
Middle name
Last name Okumura

Organization

Department of Medicine, Nihon University School of Medicine

Division name

Division of Cardiology

Zip code

173-8610

Address

30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo

TEL

03-3972-8111

Email

realaf-office@umin.org


Public contact

Name of contact person

1st name Yukimi
Middle name
Last name Kokubun

Organization

RPM Co.,Ltd

Division name

Clinical Development Div

Zip code

160-0023

Address

5F Shinwa-building,3-2-4 Nishi-shinjuku, Shinjuku-ku, Tokyo,Japan

TEL

03-5325-5821

Homepage URL


Email

realaf-office@umin.org


Sponsor or person

Institute

Division of Cardiology, Department of Medicine, Nihon University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Bristol-Myers Squibb

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nihon University Hospital, Yokohama Chuo Hospital, Kawaguchi Municipal Medical Center, Sekishindo Hospital, Tokyo Rinkai Hospital, Kasukabe Medical Center, Keiai Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nihon University Itabashi Hospital, Clinical Research Judging Committee

Address

30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo

Tel

03-3972-8111

Email

not open to the public


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

2015 Year 12 Month 08 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

881

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

Completed

Date of protocol fixation

2015 Year 03 Month 27 Day

Date of IRB

2015 Year 04 Month 10 Day

Anticipated trial start date

2016 Year 10 Month 26 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 08 Day

Date trial data considered complete

2019 Year 03 Month 12 Day

Date analysis concluded

2019 Year 03 Month 20 Day


Other

Other related information

multicenter, prospective observational study


Management information

Registered date

2015 Year 12 Month 07 Day

Last modified on

2019 Year 04 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023214


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name