- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02270151
Improving DEtection of Atrial fibriLlation in Primary Care With the MyDiagnostick (IDEAL-MD)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Utrecht, Netherlands
- GP practices
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Diagnostick strategy with MyDiagnostick
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No Intervention: Control
Control arm will perform care as usual with selective screening by feeling the pulse.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Newly detected cases of AF
Time Frame: One year
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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)
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adequate treatment of AF according the CHA2DS2-VASc score
Time Frame: one year
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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
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one year
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Major cardiovascular events and all cause mortality
Time Frame: one year
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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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one year
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Collaborators and Investigators
Sponsor
Collaborators
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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-163/C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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