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Improving DEtection of Atrial fibriLlation in Primary Care With the MyDiagnostick

NCT02270151 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16000

Last updated 2016-05-12

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

MyDiagnostick

Diagnostick strategy with MyDiagnostick

Sponsors & Collaborators

Principal Investigators

  • Frans H Rutten, MD PhD · Julius Center, UMC Utrecht

  • Arno W Hoes, MD PhD prof · Julius Center, UMC Utrecht

  • Monika Hollander, MD PhD · Julius Center, UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02270151 on ClinicalTrials.gov