Clinical trial NCT03313167: Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate
Official title: Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-10-18
Enrollment: 1316
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese population with a moderate-to high risk of stroke

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


Eligibility criteria: 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

Primary outcomes:
measure: number of subjects screened with AF identified at Index Visit
timeFrame: Up to 4 weeks
measure: number of subjects screened with AF not identified at Index Visit
timeFrame: Up to 4 weeks from Index Visit
Secondary outcomes:
measure: number of subjects with ECG-confirmed AF detected by the Omron BP device
timeFrame: Day 1 to Day 14
measure: number of subjects with ECG-confirmed AF detected by MB or HCG-801
timeFrame: Day 14 to Day 28
measure: number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy
timeFrame: 24 week follow up period
measure: 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
timeFrame: At week 24
measure: number of subjects with Paroxysmal atrial fibrillation (PAF) identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy
timeFrame: Day 1 to Day 28
measure: 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
timeFrame: At week 24
measure: number of subjects with AF identified at the Index Visit who had an ischemic stroke during the 24-week follow-up period
timeFrame: Index Visit up to week 24
measure: number of subjects with PAF identified during the extended monitoring period who had an ischemic stroke during the 24-week follow-up period
timeFrame: Day 1 up to week 24
measure: number of subjects with AF identified at the Index Visit who bled during the 24-week follow-up period
timeFrame: Index Visit up to week 24
measure: number of subjects with PAF identified during the extended monitoring period who bled during the 24-week follow-up period
timeFrame: Day 1 up to week 24
Other outcomes:
Locations:
city: Itabashi-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: