Improving DEtection of Atrial fibriLlation in Primary Care With the MyDiagnostick (IDEAL-MD)

UMC Utrecht

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Device: MyDiagnostick

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02270151

14-163/C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16,000 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16,000 participants in 2 patient groups

MyDiagnostick

Active Comparator group

Description:

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.

Treatment:

Device: MyDiagnostick

Control

No Intervention group

Description:

Control arm will perform care as usual with selective screening by feeling the pulse.