Atrial FibrillationNCT03313167
Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate
An observational study of Atrial Fibrillation, run by Bristol-Myers Squibb at 1 site in Japan.
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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Non-interventional
- How many people
- 1,316 participants
- Where
- 1 siteJapan
- Study dates
- 29 Sep 2017to 23 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Japanese population with a moderate-to high risk of stroke
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Atrial Fibrillation
- Being tested
- Non-interventional
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Non-interventional
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation-potential Patients | individuals 65 years of age or older with moderate-to-high risk of stroke Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of subjects screened with AF identified at Index Visit
Measured: 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
Measured: Up to 4 weeks from Index Visit
Secondary outcomes (10)
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
Measured: Day 1 to Day 14
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
Measured: Day 14 to Day 28
number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy
Measured: 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
Measured: At week 24
number of subjects with Paroxysmal atrial fibrillation (PAF) identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 up to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start29 Sep 2017
- Primary completion23 May 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313167
- Sponsor's protocol ID
- CV185-595
- Status last verified
- Aug 2019
- First submitted
- 12 Oct 2017
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF)
- ClinicalTrials.gov ID
- NCT03313167
- Acronym / sponsor ID
- CV185-595
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,316 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation-potential Patients | – | Other: Non-interventionalindividuals 65 years of age or older with moderate-to-high risk of stroke |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Japanese population with a moderate-to high risk of stroke
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalNon-interventional | Other | Atrial Fibrillation-potential Patients |
Primary outcome
number of subjects screened with AF identified at Index Visit
Time frame: 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
10 secondary outcomes
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 MB or HCG-801
Time frame: 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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Bristol-Myers Squibb at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of subjects screened with AF identified at Index Visit (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.