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Screening for Silent Atrial Fibrillation During Influenza Vaccination

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

'MyDiagnostick

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Silent atrial fibrillation, primary care, screening, influenza vaccination

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Eligible for influenza vaccination

Exclusion Criteria:

Not eligible for influenza vaccination

Sites / Locations

General Practices

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Screening with MyDiagnostick

Arm Description

All patients eligible for influenza vaccination are screened for atrial fibrillation with the MyDiagnostick, an easy to use and patient friendly device.

Outcomes

Primary Outcome Measures

Newly detected AF

Secondary Outcome Measures

Full Information

NCT ID

NCT02006524

First Posted

December 4, 2013

Last Updated

May 11, 2016

Sponsor

UMC Utrecht

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02006524

Brief Title

Screening for Silent Atrial Fibrillation During Influenza Vaccination

Official Title

Screening for Silent Atrial Fibrillation During Influenza Vaccination

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UMC Utrecht

Collaborators

Boehringer Ingelheim

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Silent atrial fibrillation, primary care, screening, influenza vaccination

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3269 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Screening with MyDiagnostick

Arm Type

Active Comparator

Arm Description

All patients eligible for influenza vaccination are screened for atrial fibrillation with the MyDiagnostick, an easy to use and patient friendly device.

Intervention Type

Device

Intervention Name(s)

'MyDiagnostick

Primary Outcome Measure Information:

Title

Newly detected AF

Time Frame

during influenza vaccination

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eligible for influenza vaccination Exclusion Criteria: Not eligible for influenza vaccination

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Tieleman, MD PhD

Organizational Affiliation

Martini Ziekenhuis Groningen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Monika Hollander, MD PhD

Organizational Affiliation

Julius Center UMC Utrecht

Official's Role

Principal Investigator

Facility Information:

Facility Name

General Practices

City

Groningen

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

26851813

Citation

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.

Results Reference

derived

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Screening for Silent Atrial Fibrillation During Influenza Vaccination

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