Screening for Silent Atrial Fibrillation During Influenza Vaccination

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by UMC Utrecht
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Monika Hollander, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT02006524
First received: December 4, 2013
Last updated: February 18, 2014
Last verified: December 2013

December 4, 2013
February 18, 2014
October 2013
December 2014   (final data collection date for primary outcome measure)
Newly detected AF [ Time Frame: during influenza vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02006524 on ClinicalTrials.gov Archive Site
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Screening for Silent Atrial Fibrillation During Influenza Vaccination
Screening for Silent Atrial Fibrillation During Influenza Vaccination

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).

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Atrial Fibrillation
Device: `MyDiagnostick
Active Comparator: 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.
Intervention: Device: `MyDiagnostick
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eligible for influenza vaccination

Exclusion Criteria:

  • Not eligible for influenza vaccination
Both
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Yes
Contact: Robert Tieleman, MD PhD + 31 6 29732913 r.tieleman@gmail.com
Contact: Monika Hollander, MD PhD + 31 6 28038693 M.Hollander-2@umcutrecht.nl
Netherlands
 
NCT02006524
2013-85
Yes
Monika Hollander, MD, PhD, UMC Utrecht
UMC Utrecht
Boehringer Ingelheim
Principal Investigator: Robert Tieleman, MD PhD Martini Ziekenhuis Groningen
Principal Investigator: Monika Hollander, MD PhD Julius Center UMC Utrecht
UMC Utrecht
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP