Aortic StenosisFluClinicNCT03250806
Early Detection of Aortic Stenosis in the Community During Flu Vaccination
An observational study of Aortic Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Stenosis
- How many people
- 167 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 11 Sep 2017to 30 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients identified on auscultation or target echocardiography with aortic stenosis. Consecutive patients per centre with no limit to numbers.
Who may be able to join
- Adults aged over 65years attending for influenza vaccination.
- written informed consent to data collection
Who cannot join
- known aortic stenosis
- previous aortic valve repair/replacement
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Swanswell Medical Centre
Birmingham, B27 7AL
Whaddon Medical Center
Milton Keynes, Buckinghamshire, MK3 7QU
About this study
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
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.
Read the detailed description
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.
- Conditions
- Aortic Stenosis
- Keywords
- aortic stenosis, auscultation, target echocardiography
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| newly identified aortic stenosis | Patients identified on auscultation or target echocardiography with aortic stenosis. Consecutive patients per centre with no limit to numbers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of aortic stenosis
Determination of the prevalence of aortic stenosis detected on screening performed during flu vaccination.
Measured: From date of examination until follow-up after three months
comparison of detection rate of aortic stenosis
Comparison of detection rates of aortic stenosis using target auscultation vs detection by target 2D echocardiography.
Measured: From date of examination until follow-up after three months
Secondary outcomes (2)
Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity
Method evaluation
Measured: 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.
Cost evaluation
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start11 Sep 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Richard Steeds, MD, Principal investigator, Queen Elizabeth Hospital, Birmingham, UKPeter Bramlage, MD, Study chair, IPPMed UK Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250806
- Sponsor's protocol ID
- FluClinic
- Acronym
- FluClinic
- Status last verified
- Feb 2020
- First submitted
- 1 Mar 2017
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03250806
- Acronym / sponsor ID
- FluClinic / FluClinic
- Conditions
- Aortic Stenosis
- Keywords
- aortic stenosis, auscultation, target echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Edwards Lifesciences
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newly identified aortic stenosis | – | –Patients identified on auscultation or target echocardiography with aortic stenosis. Consecutive patients per centre with no limit to numbers. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients identified on auscultation or target echocardiography with aortic stenosis. Consecutive patients per centre with no limit to numbers.
Key inclusion criteria (2 listed)
- Adults aged over 65years attending for influenza vaccination.
- written informed consent to data collection
Key exclusion criteria (2 listed)
- known aortic stenosis
- previous aortic valve repair/replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity
Time frame: 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.
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Steeds, MD principal investigator
Queen Elizabeth Hospital, Birmingham, UK
Peter Bramlage, MD study chair
IPPMed UK Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of aortic stenosis (time frame: From date of examination until follow-up after three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.