Early Detection of Aortic Stenosis in the Community During Flu Vaccination

NCT03250806 | Completed

• 1 other identifier: FluClinic
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 2

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.

Conditions

Aortic Stenosis

Keywords

aortic stenosis, auscultation, target echocardiography

Outcome Measures

Primary Outcomes (2)

• prevalence of aortic stenosis

  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

  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 Outcomes (2)

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

  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.

  three months

Study Arms (1)

newly identified aortic stenosis

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• known aortic stenosis
• previous aortic valve repair/replacement

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead
• Edwards Lifesciences: collaborator

Study Sites (2)

Whaddon Medical Center

Milton Keynes, Buckinghamshire, MK3 7QU, United Kingdom

Location

Swanswell Medical Centre

Birmingham, B27 7AL, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Richard Steeds, MD

  Queen Elizabeth Hospital, Birmingham, UK

  PRINCIPAL INVESTIGATOR

• Peter Bramlage, MD

  IPPMed UK Ltd

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: August 16, 2017
• Study Start: September 11, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)