UMIN-CTR Clinical Trial

Basic information
Public title	Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF)
Acronym	Screening for Atrial Fibrillation(AF)-potential Patients to Increase AF Detection Rate (SCAN-AF)
Scientific Title	Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF)
Scientific Title:Acronym	Screening for Atrial Fibrillation(AF)-potential Patients to Increase AF Detection Rate (SCAN-AF)
Region	Japan

Condition
Condition	Atrial Fibrillation
Classification by specialty	Cardiology Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the prevalence of all (prevalent and paroxysmal) undiagnosed AF in a Japanese population
Basic objectives2	Others
Basic objectives -Others	1)The detection rate of undiagnosed prevalent AF 2)The detection rate of PAF 3)The number of subjects with AF identified by the 9200T and by the MB or HCG-801 during extended screening in subjects who did not have AF identified by ECG at their index visit 4)The proportion of screen-detected AF patients prescribed guideline-recommended anticoagulation therapy 5)The proportion of screen-detected PAF patients prescribed guideline-recommended anticoagulation therapy 6)The proportion of screen-detected AF patients adhering to guideline-recommended anticoagulation at the end of the 24w follow up(FU) period 7)The proportion of screen-detected AF patients adhering to guideline-recommended anticoagulation at the end of the 24w FU period 8)The proportion of screen-detected AF patients who had an ischemic stroke and/or bleeding during the 24w FU period 9)The proportion of screen-detected PAF patients who had an ischemic stroke and/or bleeding the 24w FU period
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The detection rate of prevalence of all (prevalent and paroxysmal) undiagnosed atrial fibrillation (AF) in a Japanese population with moderate-to-high risk for stroke
Key secondary outcomes

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	1)65 years of age or older and one or more of the following: 2)Hypertension, prior stroke or transient ischemic attack, congestive heart failure, diabetes mellitus, and/or vascular disease
Key exclusion criteria	1)Younger than 65 years 2)Individuals with AF or a history of AF 3)Individuals taking anti-arrhythmic drugs 4)Individuals considered not suitable for participation by the investigator 5)Individuals who are not able use the monitoring devices properly and/or are unable to comply with the required procedures
Target sample size	1200

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Ryoko Suzuki
Organization	Bristol-Myers Squibb K.K.
Division name	Cardiovascular Medical
Zip code
Address	Shinjuku i-Land Tower, 5-1, Nishi-Shinjuku 6-chome, Shinjuku-ku, Tokyo 163-1328 Japan
TEL	03-6705-7000
Email	Ryoko.Suzuki@bms.com

Public contact
1st name of contact person	1st name Middle name Last name Yasuzumi Shimizu
Organization	Quintiles Transnational Japan K.K.
Division name	Real World & Late Phase Research
Zip code
Address	3-4-30 Miyahara, Yodogawa-ku, Osaka 532-0003 Japan
TEL	080-4409-9223
Homepage URL
Email	Tadakazu.Inoue@quintiles.com

Sponsor
Institute	Bristol-Myers Squibb K.K.
Institute
Department

Funding Source
Organization	Bristol-Myers Squibb K.K.
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
Address
Tel
Email

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	2017 Year 10 Month 10 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
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	2017 Year 03 Month 10 Day
Date of IRB	2017 Year 09 Month 12 Day
Anticipated trial start date	2017 Year 10 Month 10 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	1)Observational period:24w 2)Only the patients providing the informed consent will be registered.

Management information
Registered date	2017 Year 10 Month 09 Day
Last modified on	2019 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033591