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

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ClinicalTrials.gov Identifier: NCT02270151
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Monika Hollander, MD, PhD, 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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: MyDiagnostick Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Improving DEtection of Atrial fibriLlation in Primary Care With the MyDiagnostick
Study Start Date : November 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: MyDiagnostick
Diagnostick strategy with MyDiagnostick

No Intervention: Control
Control arm will perform care as usual with selective screening by feeling the pulse.



Primary Outcome Measures :
  1. Newly detected cases of AF [ Time Frame: 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 :
  1. Adequate treatment of AF according the CHA2DS2-VASc score [ Time Frame: 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

  2. Major cardiovascular events and all cause mortality [ Time Frame: 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270151


Locations
Netherlands
GP practices
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
Boehringer Ingelheim
Investigators
Principal Investigator: Frans H Rutten, MD PhD Julius Center, UMC Utrecht
Study Chair: Arno W Hoes, MD PhD prof Julius Center, UMC Utrecht
Principal Investigator: Monika Hollander, MD PhD Julius Center, UMC Utrecht

Additional Information:
Publications of Results:
Responsible Party: Monika Hollander, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02270151     History of Changes
Other Study ID Numbers: 14-163/C
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Monika Hollander, MD, PhD, UMC Utrecht:
Atrial fibrillation
Screening
Primary care
Diagnostic

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes