Early Detection of Aortic Stenosis in the Community During Flu Vaccination (FluClinic)

February 11, 2020 updated by: Institut für Pharmakologie und Präventive Medizin

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

167

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
newly identified aortic stenosis
Patients identified on auscultation or target echocardiography with aortic stenosis. Consecutive patients per centre with no limit to numbers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of aortic stenosis
Time Frame: From date of examination until follow-up after three months
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
Time Frame: 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.
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
Time Frame: three months
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.
Time Frame: three months
Cost evaluation
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut für Pharmakologie und Präventive Medizin

Collaborators

Edwards Lifesciences

Investigators

  • Principal Investigator: Richard Steeds, MD, Queen Elizabeth Hospital, Birmingham, UK
  • Study Chair: Peter Bramlage, MD, IPPMed UK Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2017

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

August 11, 2017

First Posted (Actual)

August 16, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FluClinic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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