Screening for Silent Atrial Fibrillation During Influenza Vaccination

This study has been completed.
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: May 11, 2016
Last verified: May 2016
  Purpose
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 Intervention
Atrial Fibrillation
Device: `MyDiagnostick

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Screening for Silent Atrial Fibrillation During Influenza Vaccination

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Newly detected AF [ Time Frame: during influenza vaccination ] [ Designated as safety issue: No ]

Enrollment: 3269
Study Start Date: October 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible for influenza vaccination

Exclusion Criteria:

  • Not eligible for influenza vaccination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006524

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

Responsible Party: Monika Hollander, MD, PhD, MD PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02006524     History of Changes
Other Study ID Numbers: 2013-85 
Study First Received: December 4, 2013
Last Updated: May 11, 2016
Health Authority: Medical Ethics Review Committee (METC) The Netherlands: Martini Ziekenhuis

Keywords provided by UMC Utrecht:
Silent atrial fibrillation
primary care
screening
influenza vaccination

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

ClinicalTrials.gov processed this record on August 28, 2016