Early Detection of Aortic Stenosis in the Community During Flu Vaccination (FluClinic)
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|ClinicalTrials.gov Identifier: NCT03250806|
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : February 12, 2020
|Condition or disease|
The design plans for two study phases:
- Feasibility study: screening by auscultation and target echocardiography during flu vaccination in a single practice in Birmingham;
- 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 Type :||Observational|
|Actual Enrollment :||167 participants|
|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|
newly identified aortic stenosis
Patients identified on auscultation or target echocardiography with aortic stenosis. Consecutive patients per centre with no limit to numbers.
- 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.
- 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.
- Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity [ Time Frame: three months ]Method evaluation
- 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
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
|Whaddon Medical Center|
|Milton Keynes, Buckinghamshire, United Kingdom, MK3 7QU|
|Swanswell Medical Centre|
|Birmingham, United Kingdom, B27 7AL|
|Principal Investigator:||Richard Steeds, MD||Queen Elizabeth Hospital, Birmingham, UK|
|Study Chair:||Peter Bramlage, MD||IPPMed UK Ltd|