Early Detection of Aortic Stenosis in the Community During Flu Vaccination

Completed

• Conditions: Aortic Stenosis

• Registration Number: NCT03250806
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-16
• Study Start: 2017-09-11
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of detection rate of aortic stenosis	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.
prevalence of aortic stenosis	From date of examination until follow-up after three months	Determination of the prevalence of aortic stenosis detected on screening performed during flu vaccination.

Secondary Outcome Measures

Name	Time	Method
Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity	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.	three months	Cost evaluation

Trial Locations

Locations (2)

Whaddon Medical Center; 🇬🇧 Milton Keynes, Buckinghamshire, United Kingdom

Swanswell Medical Centre; 🇬🇧 Birmingham, United Kingdom