- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03313167
Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate
August 7, 2019 updated by: Bristol-Myers Squibb
Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF)
To assess the prevalence of all (prevalent and paroxysmal) undiagnosed atrial fibrillation (AF) in a Japanese population with a moderate-to-high risk of stroke
Study Overview
Study Type
Observational
Enrollment (Actual)
1316
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo
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Itabashi-ku, Tokyo, Japan, 173-0003
- Local Institution
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Japanese population with a moderate-to high risk of stroke
Description
Inclusion Criteria:
- Age ≥ 65 and one or more of the following: hypertension, prior stroke or transient ischemic attack, congestive heart failure, diabetes mellitus, and/or vascular disease
Exclusion Criteria:
- Age < 65 years, individuals with AF or a history of AF, or individuals taking anti-arrhythmic drugs
Other protocol defined inclusion/exclusion criteria could apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Atrial Fibrillation-potential Patients
individuals 65 years of age or older with moderate-to-high risk of stroke
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Non-interventional
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of subjects screened with AF identified at Index Visit
Time Frame: Up to 4 weeks
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Up to 4 weeks
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number of subjects screened with AF not identified at Index Visit
Time Frame: Up to 4 weeks from Index Visit
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number of subjects screened who have AF not identified at their Index Visit but subsequently found to have AF confirmed by 12-lead Electrocardiogram (ECG) during the extended monitoring period
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Up to 4 weeks from Index Visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of subjects with ECG-confirmed AF detected by the Omron BP device
Time Frame: Day 1 to Day 14
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number of subjects with ECG-confirmed AF detected by the Omron blood pressure (BP) device during the extended monitoring period
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Day 1 to Day 14
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number of subjects with ECG-confirmed AF detected by MB or HCG-801
Time Frame: Day 14 to Day 28
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number of subjects with ECG-confirmed AF detected by MyBeat (MB) or Omron HeartScan 801 (HCG-801) during the extended monitoring period
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Day 14 to Day 28
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number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy
Time Frame: 24 week follow up period
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24 week follow up period
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number of subjects with AF identified at their Index Visit who are prescribed guideline recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up period
Time Frame: At week 24
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At week 24
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number of subjects with Paroxysmal atrial fibrillation (PAF) identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy
Time Frame: Day 1 to Day 28
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Day 1 to Day 28
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number of subjects with PAF identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up
Time Frame: At week 24
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At week 24
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number of subjects with AF identified at the Index Visit who had an ischemic stroke during the 24-week follow-up period
Time Frame: Index Visit up to week 24
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Index Visit up to week 24
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number of subjects with PAF identified during the extended monitoring period who had an ischemic stroke during the 24-week follow-up period
Time Frame: Day 1 up to week 24
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Day 1 up to week 24
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number of subjects with AF identified at the Index Visit who bled during the 24-week follow-up period
Time Frame: Index Visit up to week 24
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Index Visit up to week 24
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number of subjects with PAF identified during the extended monitoring period who bled during the 24-week follow-up period
Time Frame: Day 1 up to week 24
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Day 1 up to week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2017
Primary Completion (Actual)
May 23, 2019
Study Completion (Actual)
May 23, 2019
Study Registration Dates
First Submitted
October 12, 2017
First Submitted That Met QC Criteria
October 17, 2017
First Posted (Actual)
October 18, 2017
Study Record Updates
Last Update Posted (Actual)
August 9, 2019
Last Update Submitted That Met QC Criteria
August 7, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV185-595
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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