Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Screening, Primary care, Diagnostic
Brief summary
Atrial fibrillation (AF) is the most common arrhythmia and a common cause of stroke. AF can be asymptomatic and remain undiagnosed. Both the prevalence of AF and the proportion of strokes related to undetected AF increases with ageing. If AF is timely diagnosed and treated accordingly with anticoagulants, disabling strokes can be prevented. In order to help physicians in diagnosing atrial fibrillation, the MyDiagnostick was developed. It is a CE certified device that is safe, user friendly and easy to use. This device is capable of detecting or excluding AF within one minute by providing a registration of lead I of the ECG. The investigators aim to perform a 2-arm cluster randomized diagnostic trial among patients aged 65 years and over who visit the general practice. In total the investigators will include 42 general practices of which they randomly assign 21 to the MyDiagnostick arm and 21 to the control arm. All persons aged 65 years and over who visit the general practice in the MyDiagnostick arm will be asked to hold the device every time they visit the surgery during one year. The number of newly detected cases of AF with the diagnostic screening strategy with MyDiagnostick (MyDiagnostick arm) will be compared to care as usual (control arm). Also, the number of patients treated with anticoagulants according CHA2DS2-VASc score will be compared between both arms. Finally, the investigators will assess the number of major adverse cardiovascular events (MACE), intracerebral hemorrhages and other major hemorrhages, and all-cause mortality between the arms. End points will be assessed blinded to allocation. The investigators hypothesise that the MyDiagnostick improves the diagnosis of atrial fibrillation in primary care and with accordingly treatment will reduce adverse outcomes.
Detailed description
In a recent validation study performed in 200 patients visiting a cardiology outpatient clinic, the sensitivity was 100%, and specificity 96.4% with the MyDiagnostics as compared to a 12-lead ECG. Adequate comparison of this device with accordingly treatment with care as usual is needed before large scale implementation in the primary care setting can be advocated.
Interventions
DEVICEMyDiagnostick
Diagnostick strategy with MyDiagnostick
Sponsors
Boehringer Ingelheim
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Community dwelling persons visit the GP and aged 65 years of over
Exclusion criteria
* Terminal illness of such severity that anticoagulation is considered to be not appropriate in case of newly detected atrial fibrillation * Acute situation in which GP should act instantly * Patients with a history of AF
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Newly detected cases of AF | One year | For our primary outcome the investigators will calculate the number of atrial fibrillation as detected with MyDiagnostick (MyDiagnostick arm) as compared to care as usual in primary care (control arm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adequate treatment of AF according the CHA2DS2-VASc score | one year | The investigators will compare anticoagulant treatment in newly detected AF patients in the MyDiagnostick with the number of those receiving anticoagulant treatment in new AF cases in the control arm |
| Major cardiovascular events and all cause mortality | one year | The investigators will compare major cardiovascular events (ischemic strokes, intracerebral hemorrhages and other major hemorrhages, myocardial infarction, CABG, PCA), and all cause mortality between the MyDiagnostick arm and the control arm within one year after the start of the study. |
Countries
Netherlands
Outcome results
None listed