Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate
Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF)
1 other identifier
observational
1,316
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 29, 2017
CompletedFirst Submitted
Initial submission to the registry
October 12, 2017
CompletedFirst Posted
Study publicly available on registry
October 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2019
CompletedAugust 9, 2019
August 1, 2019
1.6 years
October 12, 2017
August 7, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (10)
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 MB or HCG-801
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
- +5 more secondary outcomes
Study Arms (1)
Atrial Fibrillation-potential Patients
individuals 65 years of age or older with moderate-to-high risk of stroke
Interventions
Eligibility Criteria
Japanese population with a moderate-to high risk of stroke
You may qualify if:
- 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
You may not qualify if:
- Age \< 65 years, individuals with AF or a history of AF, or individuals taking anti-arrhythmic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Itabashi-ku, Tokyo, 173-0003, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2017
First Posted
October 18, 2017
Study Start
September 29, 2017
Primary Completion
May 23, 2019
Study Completion
May 23, 2019
Last Updated
August 9, 2019
Record last verified: 2019-08