Early Detection of Aortic Stenosis in the Community During Flu Vaccination

NCT ID: NCT03250806

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-11

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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newly identified aortic stenosis

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role collaborator

Institut für Pharmakologie und Präventive Medizin

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Steeds, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth Hospital, Birmingham, UK

Peter Bramlage, MD

Role: STUDY_CHAIR

IPPMed UK Ltd

Locations

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Whaddon Medical Center

Milton Keynes, Buckinghamshire, United Kingdom

Site Status

Swanswell Medical Centre

Birmingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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FluClinic

Identifier Type: -

Identifier Source: org_study_id

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