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Clinical Trials/NCT03250806
NCT03250806
Completed
Not Applicable

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

Institut für Pharmakologie und Präventive Medizin2 sites in 1 country167 target enrollmentSeptember 11, 2017
ConditionsAortic Stenosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Stenosis
Sponsor
Institut für Pharmakologie und Präventive Medizin
Enrollment
167
Locations
2
Primary Endpoint
comparison of detection rate of aortic stenosis
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 11, 2017
End Date
November 30, 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Institut für Pharmakologie und Präventive Medizin
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • 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 Sites (2)

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