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OpenTrials
Completed

NCT Number: NCT03313167

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

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

Completed

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Itabashi-ku, Tokyo, 173-0003, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-interventional

Primary outcomes

  1. number of subjects screened with AF identified at Index Visit

    Time frame: Up to 4 weeks

  2. number of subjects screened with AF not identified at Index Visit

    Time frame: 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 outcomes

  1. number of subjects with ECG-confirmed AF detected by the Omron BP device

    Time frame: 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

  2. number of subjects with ECG-confirmed AF detected by MB or HCG-801

    Time frame: 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

  3. number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy

    Time frame: 24 week follow up period

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2017
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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