Improving DEtection of Atrial fibriLlation in Primary Care With the MyDiagnostick

NCT02270151 | Completed Phase 3

• 1 other identifier: 14-163/C
• Study Type: interventional
• Target: 16,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Screening; Primary care; Diagnostic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Adequate treatment of AF according the CHA2DS2-VASc score

  one year

• Major cardiovascular events and all cause mortality

  one year

Study Arms (2)

MyDiagnostick

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Control arm will perform care as usual with selective screening by feeling the pulse.

Interventions

MyDiagnostick DEVICE

Diagnostick strategy with MyDiagnostick

MyDiagnostick

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Community dwelling persons visit the GP and aged 65 years of over

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

GP practices

Utrecht, Utrecht, Netherlands

Location

Related 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 (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.

  PMID: 11343485 RESULT

• 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.

  PMID: 16527828 RESULT

• 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.

  PMID: 8841326 RESULT

• 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.

  PMID: 17577005 RESULT

Related Links

• ESC Guidelines 2010
• ESC Guidelines 2012

MeSH Terms

Conditions

Atrial Fibrillation; Disease

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frans H Rutten, MD PhD

  Julius Center, UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Arno W Hoes, MD PhD prof

  Julius Center, UMC Utrecht

  STUDY CHAIR

• Monika Hollander, MD PhD

  Julius Center, UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Monika Hollander, MD, PhD

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: October 21, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

NL (1)