Early Detection of Aortic Stenosis in the Community During Flu Vaccination

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03250806

Acronym

FluClinic

Enrollment

167

Registered

2017-08-16

Start date

2017-09-11

Completion date

2017-11-30

Last updated

2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

aortic stenosis, auscultation, target echocardiography

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results