Improving DEtection of Atrial fibriLlation in Primary Care With the MyDiagnostick

Atrial Fibrillation Clinical Trial

— IDEAL-MD  

Official title:

Improving DEtection of Atrial fibriLlation in Primary Care With the MyDiagnostick

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270151
• Other study ID #: 14-163/C
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2014
• Last updated: May 11, 2016
• Start date: November 2014
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16000
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• MyDiagnostick
Diagnostick strategy with MyDiagnostick

Locations

Country	Name	City	State
Netherlands	GP practices	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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 ( — View Citation

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. — View Citation

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. Epub 2006 Mar 9. — View Citation

Jørgensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Newly detected cases of AF	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)	One year	No
Secondary	Adequate treatment of AF according the CHA2DS2-VASc score	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	one year	No
Secondary	Major cardiovascular events and all cause mortality	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.	one year	No

External Links

•   ESC Guidelines 2010
•   ESC Guidelines 2012
•   Guidelines for AF in primary care