Early Detection of Aortic Stenosis in the Community During Flu Vaccination

Aortic Stenosis Clinical Trial

— FluClinic  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250806
• Other study ID #: FluClinic
• Status: Completed
• Start date: September 11, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: February 2020
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Locations

Country	Name	City	State
United Kingdom	Swanswell Medical Centre	Birmingham
United Kingdom	Whaddon Medical Center	Milton Keynes	Buckinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Edwards Lifesciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity	Method evaluation	three months
Secondary	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	three months