Atrial FibrillationNCT02006524
Screening for Silent Atrial Fibrillation During Influenza Vaccination
A study testing 'MyDiagnostick in people with Atrial Fibrillation, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Silent atrial fibrillation is an important cause of unnecessary strokes. If diagnosed and treated in time with anticoagulants, many disabling strokes can be prevented. In order to improve the diagnosis of atrial fibrillation the MyDiagnostick is developed; a user friendly and easy to use stick that diagnoses atrial… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- 'MyDiagnostick
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,269 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2013to Dec 2014
- Phase
- Interventional
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Eligible for influenza vaccination
Who cannot join
- Not eligible for influenza vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Silent atrial fibrillation is an important cause of unnecessary strokes. If diagnosed and treated in time with anticoagulants, many disabling strokes can be prevented. In order to improve the diagnosis of atrial fibrillation the MyDiagnostick is developed; a user friendly and easy to use stick that diagnoses atrial fibrillation in one minute. During influenza vaccination, many patients who are also at risk for atrial fibrillation visit the general practice. This offers an ideal opportunity for screening for atrial fibrillation. The study investigates the yield of screening for atrial fibrillation with the MyDiagnostick during influenza vaccination (newly detected atrial fibrillation with corresponding CHA2DS2-Vasc score).
- Conditions
- Atrial Fibrillation
- Being tested
- 'MyDiagnostick
- Keywords
- Silent atrial fibrillation, primary care, screening, influenza vaccination
- Medical subject headings
- Atrial Fibrillation, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'MyDiagnostickDevice
| Study group | Role | What they receive |
|---|---|---|
| Screening with MyDiagnostick | Active comparator | All patients eligible for influenza vaccination are screened for atrial fibrillation with the MyDiagnostick, an easy to use and patient friendly device. Receives: Device: 'MyDiagnostick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newly detected AF
Measured: during influenza vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,269 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Monika Hollander, MD, PhD, UMC Utrecht
- Investigators
- Robert Tieleman, MD PhD, Principal investigator, Martini Ziekenhuis GroningenMonika Hollander, MD PhD, Principal investigator, Julius Center UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006524
- Sponsor's protocol ID
- 2013-85
- Status last verified
- May 2016
- First submitted
- 4 Dec 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kaasenbrood F, Hollander M, Rutten FH, Gerhards LJ, Hoes AW, Tieleman RG. Yield of screening for atrial fibrillation in primary care with a hand-held, single-lead electrocardiogram device during influenza vaccination. Europace. 2016 Oct;18(10):1514-1520. doi: 10.1093/europace/euv426. Epub 2016 Feb 6.
PubMed 26851813