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CompletedNCT03250806FluClinicUpdated Feb 12, 2020

Early Detection of Aortic Stenosis in the Community During Flu Vaccination

An observational study in Aortic Stenosis, sponsored by Institut für Pharmakologie und Präventive Medizin. Completed at 2 sites in United Kingdom. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-02-12.

Sponsored by Institut für Pharmakologie und Präventive Medizin · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
167
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aortic Stenosis

Keywords

  • aortic stenosis, auscultation, target echocardiography
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Adults aged over 65years attending for influenza vaccination.
  • written informed consent to data collection

Exclusion criteria

Exclusion Criteria:

  • known aortic stenosis
  • previous aortic valve repair/replacement
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
167 participants (actual)
Patient registry
No

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.

05

What researchers measure

Primary outcomes

  1. prevalence of aortic stenosis

    Determination of the prevalence of aortic stenosis detected on screening performed during flu vaccination.

    Time frame: From date of examination until follow-up after three months

  2. comparison of detection rate of aortic stenosis

    Comparison of detection rates of aortic stenosis using target auscultation vs detection by target 2D echocardiography.

    Time frame: From date of examination until follow-up after three months

Secondary outcomes

  1. Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity

    Method evaluation

    Time frame: three months

  2. 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

    Time frame: three months

06

Study locations

2 sites
  • Whaddon Medical Center
    Milton Keynes, Buckinghamshire MK3 7QU, United Kingdom
  • Swanswell Medical Centre
    Birmingham, B27 7AL, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03250806
Lead sponsor
Institut für Pharmakologie und Präventive Medizin
Collaborators
Edwards Lifesciences
Responsible party
Sponsor
First posted
Aug 16, 2017
Start date
Sep 11, 2017
Primary completion
Nov 30, 2017
Completion
Nov 30, 2017
Last update
Feb 12, 2020

Study contacts

Richard Steeds, MD
principal investigator · Queen Elizabeth Hospital, Birmingham, UK
Peter Bramlage, MD
study chair · IPPMed UK Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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