Screening for Silent Atrial Fibrillation During Influenza Vaccination

Atrial Fibrillation Clinical Trial

Official title:

Screening for Silent Atrial Fibrillation During Influenza Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006524
• Other study ID #: 2013-85
• Status: Completed
• Phase: N/A
• First received: December 4, 2013
• Last updated: May 11, 2016
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2016
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Medical Ethics Review Committee (METC) The Netherlands: Martini Ziekenhuis
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3269
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Eligible for influenza vaccination

Exclusion Criteria:

• Not eligible for influenza vaccination

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• `MyDiagnostick

Locations

Country	Name	City	State
Netherlands	General Practices	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Newly detected AF		during influenza vaccination	No