Atrial Fibrillation
Conditions
Brief summary
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
Interventions
OTHERNon-interventional
Non-interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 4 weeks from 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 ECG-confirmed AF detected by the Omron BP device | Day 1 to Day 14 | number of subjects with ECG-confirmed AF detected by the Omron blood pressure (BP) device during the extended monitoring period |
| number of subjects with ECG-confirmed AF detected by MB or HCG-801 | Day 14 to Day 28 | number of subjects with ECG-confirmed AF detected by MyBeat (MB) or Omron HeartScan 801 (HCG-801) during the extended monitoring period |
| 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 bled 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 | — |
Countries
Japan
Outcome results
None listed