Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate

Atrial Fibrillation Clinical Trial

Official title:

Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313167
• Other study ID #: CV185-595
• Status: Completed
• Start date: September 29, 2017
• Est. completion date: May 23, 2019

Study information

• Verified date: August 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1316
• Est. completion date: May 23, 2019
• Est. primary completion date: May 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Non-interventional
Non-interventional

Locations

Country	Name	City	State
Japan	Local Institution	Itabashi-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of subjects screened with AF identified at Index Visit		Up to 4 weeks
Primary	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
Secondary	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
Secondary	number of subjects with ECG-confirmed AF detected by MB or HCG-801	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
Secondary	number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy		24 week follow up period
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
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