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Screening for Silent Atrial Fibrillation During Influenza Vaccination

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02006524
First Posted: December 10, 2013
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Monika Hollander, MD, PhD, UMC Utrecht
December 4, 2013
December 10, 2013
May 12, 2016
October 2013
December 2014   (Final data collection date for primary outcome measure)
Newly detected AF [ Time Frame: during influenza vaccination ]
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: None (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
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. Epub 2016 Feb 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3269
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
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT02006524
2013-85
Yes
Not Provided
Not Provided
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
May 2016

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