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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03250806
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

Study Description
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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.

Condition or disease
Aortic Stenosis

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 Design
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Study Type : Observational
Actual Enrollment : 167 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity [ Time Frame: three months ]
    Method evaluation

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250806


Locations
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United Kingdom
Whaddon Medical Center
Milton Keynes, Buckinghamshire, United Kingdom, MK3 7QU
Swanswell Medical Centre
Birmingham, United Kingdom, B27 7AL
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Edwards Lifesciences
Investigators
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Principal Investigator: Richard Steeds, MD Queen Elizabeth Hospital, Birmingham, UK
Study Chair: Peter Bramlage, MD IPPMed UK Ltd
More Information
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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT03250806    
Other Study ID Numbers: FluClinic
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut für Pharmakologie und Präventive Medizin:
aortic stenosis, auscultation, target echocardiography
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction