Early Detection of Aortic Stenosis in the Community During Flu Vaccination

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Aortic Stenosis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| newly identified aortic stenosis<br>Patients identified on auscultation or target echocardiography with aortic stenosis. Consecutive patients per centre with no limit to numbers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of aortic stenosis | Determination of the prevalence of aortic stenosis detected on screening performed during flu vaccination. | From date of examination until follow-up after three months | 
| comparison of detection rate of aortic stenosis | Comparison of detection rates of aortic stenosis using target auscultation vs detection by target 2D echocardiography. | From date of examination until follow-up after three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity | Method evaluation | three months | 
| Calculation of costs in screening with auscultation versus target 2DE in screening for AS to inform future cost-efficacy studies of screening for AS. | Cost evaluation | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic stenosis, auscultation, target echocardiography