Improving DEtection of Atrial fibriLlation in Primary Care With the MyDiagnostick

Phase 3

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: MyDiagnostick

• Registration Number: NCT02270151
• Lead Sponsor: UMC Utrecht

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.

Study Timeline

• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-21
• Study Start: 2014-11
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MyDiagnostick	MyDiagnostick	Everyone aged 65 years or over, who visits the GP practice will be screened for AF with the MyDiagnostick. When the device indicates a positive result, the single lead ECG will be assessed to confirm/reject the diagnosis. Every new case of diagnosed AF will be evaluated for further treatment by the general practitioner.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

GP practices; 🇳🇱 Utrecht, Netherlands