Clinical trial NCT02270151: Improving DEtection of Atrial fibriLlation in Primary Care With the MyDiagnostick
Official title: Improving DEtection of Atrial fibriLlation in Primary Care With the MyDiagnostick
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Screening
Primary care
Diagnostic
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2014-10-21
Enrollment: 16000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Newly detected cases of AF
timeFrame: One year
Secondary outcomes:
measure: Adequate treatment of AF according the CHA2DS2-VASc score
timeFrame: one year
measure: Major cardiovascular events and all cause mortality
timeFrame: one year
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: GP practices
Study officials:
affiliation: Julius Center, UMC Utrecht
name: Frans H Rutten, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Julius Center, UMC Utrecht
name: Arno W Hoes, MD PhD prof
role: STUDY_CHAIR
affiliation: Julius Center, UMC Utrecht
name: Monika Hollander, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.
citation: Heeringa J, van der Kuip DA, Hofman A, Kors JA, van Herpen G, Stricker BH, Stijnen T, Lip GY, Witteman JC. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J. 2006 Apr;27(8):949-53. doi: 10.1093/eurheartj/ehi825. Epub 2006 Mar 9.
citation: Jorgensen HS, Nakayama H, Reith J, Raaschou HO, Olsen TS. Acute stroke with atrial fibrillation. The Copenhagen Stroke Study. Stroke. 1996 Oct;27(10):1765-9. doi: 10.1161/01.str.27.10.1765.
citation: Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.