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Completed

NCT Number: NCT03250806

Early Detection of Aortic Stenosis in the Community During Flu Vaccination

Prospective cohort study to test the hypothesis that patients identified with severe aortic stenosis are under-diagnosed and under-treated. Such patients shall be identified by auscultation or target echocardiography during flu vaccination. The hypothesis is that this will increase detection of aortic stenosis in the community.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Whaddon Medical Center, Milton Keynes, Buckinghamshire, United Kingdom

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About this study

The design plans for two study phases:

  • Feasibility study: screening by auscultation and target echocardiography during flu vaccination in a single practice in Birmingham;
  • Screening study: multi-centre screening by auscultation or target echocardiography in geographically diverse general practices across the United Kingdom.

In each phase, the patient will be identified by auscultation and target echocardiography. Management and onward referral will be at the clinical discretion of the GP. Results of clinical review, investigation, follow-up and management will be recorded at 3 months from that date.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged over 65years attending for influenza vaccination.
  • written informed consent to data collection

Exclusion criteria

  • known aortic stenosis
  • previous aortic valve repair/replacement

Treatment and study plan

Primary outcomes

  1. prevalence of aortic stenosis

    Time frame: From date of examination until follow-up after three months

    Determination of the prevalence of aortic stenosis detected on screening performed during flu vaccination.

  2. comparison of detection rate of aortic stenosis

    Time frame: From date of examination until follow-up after three months

    Comparison of detection rates of aortic stenosis using target auscultation vs detection by target 2D echocardiography.

Secondary outcomes

  1. Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity

    Time frame: three months

    Method evaluation

  2. Calculation of costs in screening with auscultation versus target 2DE in screening for AS to inform future cost-efficacy studies of screening for AS.

    Time frame: three months

    Cost evaluation

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

Early Detection of Aortic Stenosis in the Community: Role of Clinical and Echocardiographic Screening During Influenza Vaccination Multi-center, Prospective, Observational Cohort Study

Acronym: FluClinic

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 16, 2017
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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