Screening for Silent Atrial Fibrillation During Influenza Vaccination

NCT ID: NCT02006524

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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Silent atrial fibrillation is an important cause of unnecessary strokes. If diagnosed and treated in time with anticoagulants, many disabling strokes can be prevented. In order to improve the diagnosis of atrial fibrillation the MyDiagnostick is developed; a user friendly and easy to use stick that diagnoses atrial fibrillation in one minute. During influenza vaccination, many patients who are also at risk for atrial fibrillation visit the general practice. This offers an ideal opportunity for screening for atrial fibrillation. The study investigates the yield of screening for atrial fibrillation with the MyDiagnostick during influenza vaccination (newly detected atrial fibrillation with corresponding CHA2DS2-Vasc score).

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Screening with MyDiagnostick

All patients eligible for influenza vaccination are screened for atrial fibrillation with the MyDiagnostick, an easy to use and patient friendly device.

Group Type ACTIVE_COMPARATOR

'MyDiagnostick

Intervention Type DEVICE

Interventions

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'MyDiagnostick

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Eligible for influenza vaccination

Exclusion Criteria

* Not eligible for influenza vaccination
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Monika Hollander, MD, PhD

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Tieleman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Martini Ziekenhuis Groningen

Monika Hollander, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Julius Center UMC Utrecht

Locations

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General Practices

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

References

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Kaasenbrood F, Hollander M, Rutten FH, Gerhards LJ, Hoes AW, Tieleman RG. Yield of screening for atrial fibrillation in primary care with a hand-held, single-lead electrocardiogram device during influenza vaccination. Europace. 2016 Oct;18(10):1514-1520. doi: 10.1093/europace/euv426. Epub 2016 Feb 6.

Reference Type DERIVED
PMID: 26851813 (View on PubMed)

Other Identifiers

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2013-85

Identifier Type: -

Identifier Source: org_study_id

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