Clinical trial NCT03250806: Early Detection of Aortic Stenosis in the Community During Flu Vaccination
Official title: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: aortic stenosis, auscultation, target echocardiography
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Edwards Lifesciences
First posted: 2017-08-16
Enrollment: 167
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients identified on auscultation or target echocardiography with aortic stenosis. Consecutive patients per centre with no limit to numbers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: prevalence of aortic stenosis
timeFrame: From date of examination until follow-up after three months
measure: comparison of detection rate of aortic stenosis
timeFrame: From date of examination until follow-up after three months
Secondary outcomes:
measure: Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity
timeFrame: three months
measure: Calculation of costs in screening with auscultation versus target 2DE in screening for AS to inform future cost-efficacy studies of screening for AS.
timeFrame: three months
Other outcomes:
Locations:
city: Milton Keynes
country: United Kingdom
facility: Whaddon Medical Center
state: Buckinghamshire
city: Birmingham
country: United Kingdom
facility: Swanswell Medical Centre
Study officials:
affiliation: Queen Elizabeth Hospital, Birmingham, UK
name: Richard Steeds, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IPPMed UK Ltd
name: Peter Bramlage, MD
role: STUDY_CHAIR
References: