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

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

Study Description

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

Additional Information:

ESC Guidelines 2010  ESC Guidelines 2012 

Publications of Results:

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.

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.

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.

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.

• Responsible Party: Monika Hollander, MD, PhD, UMC Utrecht
• ClinicalTrials.gov Identifier: NCT02270151
• Other Study ID Numbers: 14-163/C
• First Posted: October 21, 2014
• 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