Screening for Silent Atrial Fibrillation During Influenza Vaccination
1 other identifier
interventional
3,269
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Oct 2013
Shorter than P25 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 4, 2013
CompletedFirst Posted
Study publicly available on registry
December 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 12, 2016
May 1, 2016
1.2 years
December 4, 2013
May 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Newly detected AF
during influenza vaccination
Study Arms (1)
Screening with MyDiagnostick
ACTIVE COMPARATORAll patients eligible for influenza vaccination are screened for atrial fibrillation with the MyDiagnostick, an easy to use and patient friendly device.
Interventions
Eligibility Criteria
You may qualify if:
- Eligible for influenza vaccination
You may not qualify if:
- Not eligible for influenza vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- Boehringer Ingelheimcollaborator
Study Sites (1)
General Practices
Groningen, Provincie Groningen, Netherlands
Related Publications (1)
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.
PMID: 26851813DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Tieleman, MD PhD
Martini Ziekenhuis Groningen
- PRINCIPAL INVESTIGATOR
Monika Hollander, MD PhD
Julius Center UMC Utrecht
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
December 4, 2013
First Posted
December 10, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
May 12, 2016
Record last verified: 2016-05