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

August 7, 2019 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1316

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tokyo
      • Itabashi-ku, Tokyo, Japan, 173-0003
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Japanese population with a moderate-to high risk of stroke

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atrial Fibrillation-potential Patients
individuals 65 years of age or older with moderate-to-high risk of stroke
Non-interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of subjects screened with AF identified at Index Visit
Time Frame: Up to 4 weeks
Up to 4 weeks
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
Up to 4 weeks from Index Visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1 to Day 14
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
Day 14 to Day 28
number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy
Time Frame: 24 week follow up period
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
Time Frame: At week 24
At week 24
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
Day 1 to Day 28
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
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
Time Frame: Index Visit up to week 24
Index Visit up to week 24
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
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
Time Frame: Index Visit up to week 24
Index Visit up to week 24
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
Day 1 up to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2017

Primary Completion (Actual)

May 23, 2019

Study Completion (Actual)

May 23, 2019

Study Registration Dates

First Submitted

October 12, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CV185-595

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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