UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029473 |
|---|---|
| Receipt number | R000033591 |
| Scientific Title | Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF) |
| Date of disclosure of the study information | 2017/10/10 |
| Last modified on | 2019/04/11 16:45:48 |
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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
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
Ryoko.Suzuki@bms.com
Public contact
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
Tadakazu.Inoue@quintiles.com
Sponsor or person
Institute
Bristol-Myers Squibb K.K.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033591
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
