Early Detection of Aortic Stenosis in the Community During Flu Vaccination

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 30, 2017

Detailed Description

The design plans for two study phases: 1. Feasibility study: screening by auscultation and target echocardiography during flu vaccination in a single practice in Birmingham; 2. 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.

Arms, Groups and Cohorts

  • newly identified aortic stenosis
    • Patients identified on auscultation or target echocardiography with aortic stenosis. Consecutive patients per centre with no limit to numbers.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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 Measures

  • Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity
    • Time Frame: three months
    • Method evaluation
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut für Pharmakologie und Präventive Medizin
  • Collaborator
    • Edwards Lifesciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard Steeds, MD, Principal Investigator, Queen Elizabeth Hospital, Birmingham, UK
    • Peter Bramlage, MD, Study Chair, IPPMed UK Ltd

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