Screening for Silent Atrial Fibrillation During Influenza Vaccination

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. Identifier: NCT02006524
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : May 12, 2016
Boehringer Ingelheim
Information provided by (Responsible Party):
Monika Hollander, MD, PhD, UMC Utrecht

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: `MyDiagnostick Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3269 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Screening for Silent Atrial Fibrillation During Influenza Vaccination
Study Start Date : October 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Device: `MyDiagnostick

Primary Outcome Measures :
  1. Newly detected AF [ Time Frame: during influenza vaccination ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Eligible for influenza vaccination

Exclusion Criteria:

  • Not eligible for influenza vaccination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02006524

General Practices
Groningen, Netherlands
Sponsors and Collaborators
UMC Utrecht
Boehringer Ingelheim
Principal Investigator: Robert Tieleman, MD PhD Martini Ziekenhuis Groningen
Principal Investigator: Monika Hollander, MD PhD Julius Center UMC Utrecht

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Monika Hollander, MD, PhD, MD PhD, UMC Utrecht Identifier: NCT02006524     History of Changes
Other Study ID Numbers: 2013-85
First Posted: December 10, 2013    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Monika Hollander, MD, PhD, UMC Utrecht:
Silent atrial fibrillation
primary care
influenza vaccination

Additional relevant MeSH terms:
Influenza, Human
Atrial Fibrillation
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs