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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial Fibrillation-potential Patients | individuals 65 years of age or older with moderate-to-high risk of stroke |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | Non-interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of subjects screened with AF identified at Index Visit | Up to 4 weeks | |
| number of subjects screened with AF not identified at Index Visit | 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 | Up to 4 weeks from Index Visit |
| Measure | Description | Time Frame |
|---|---|---|
| number of subjects with ECG-confirmed AF detected by the Omron BP device | number of subjects with ECG-confirmed AF detected by the Omron blood pressure (BP) device during the extended monitoring period | Day 1 to Day 14 |
| number of subjects with ECG-confirmed AF detected by MB or HCG-801 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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Japanese population with a moderate-to high risk of stroke
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Itabashi-ku | Tokyo | 173-0003 | Japan |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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 |
| Day 14 to Day 28 |
| number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy | 24 week follow up period |
| 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 | At week 24 |
| number of subjects with Paroxysmal atrial fibrillation (PAF) identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy | Day 1 to Day 28 |
| 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 | At week 24 |
| number of subjects with AF identified at the Index Visit who had an ischemic stroke during the 24-week follow-up period | Index Visit up to week 24 |
| number of subjects with PAF identified during the extended monitoring period who had an ischemic stroke during the 24-week follow-up period | Day 1 up to week 24 |
| number of subjects with AF identified at the Index Visit who bled during the 24-week follow-up period | Index Visit up to week 24 |
| number of subjects with PAF identified during the extended monitoring period who bled during the 24-week follow-up period | Day 1 up to week 24 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |