Aortic StenosisELASTIC-ASNCT03883490
Role of Elastin Metabolites in Aortic Remodelling in AS
An observational study of Aortic Stenosis, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Around 1-2% of people are born with a 'bicuspid' aortic valve, with only two cusps instead of the common 'tri-leaflet' valve. People with this valve develop dysfunction of the valve (narrowing or leakage) at a much earlier age. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- ECG, Blood test and biobanking and Trans-thoracic Echocardiogram
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jun 2019to 31 Aug 2023
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients listed for a surgical aortic valve replacement (with or without coronary artery bypass graft) for severe aortic stenosis of bicuspid (n=15) and tri-leaflet (n=15) aortic valves will be potentially eligible to participate in this study.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Age 18 years or above.
- Planned surgical AVR (+/- CABG or aortic root surgery) for severe AS.
- Ability to understand the written information in English.
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Contraindication to MRI (e.g., non-compatible pacemaker or other device).
- Severe claustrophobia (unable to have MRI scan).
- eGFR<30ml/min (contra-indication to have contrast agent during MRI).
- Contraindication to Adenosine (severe asthma).
- Significant arrhythmia.
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- Other valve disease > moderate in severity.
- Female participants who are pregnant or lactating.
- Previous aortic valve or aorta surgery, previous CABG or other surgery involving aortic cross clamping.
- Participant in an interventional cardiovascular clinical trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester NHS Trust
Leicester
About this study
Official title: A Pilot Study of ELastin Metabolites and Aortic Remodelling Following Surgery for Tricuspid and bICuspid Aortic Stenosis (ELASTIC-AS)
Around 1-2% of people are born with a 'bicuspid' aortic valve, with only two cusps instead of the common 'tri-leaflet' valve. People with this valve develop dysfunction of the valve (narrowing or leakage) at a much earlier age. It is also more common for them to develop enlargement of the main blood vessel coming out of the heart, the aorta, and some studies suggest that they are also at higher risk of life-threatening tears in the aortic wall. Current guidelines recommend surgical replacement of the aorta at an earlier stage in these patients. The exact mechanism for the dilatation is not clear, and some studies have suggested greater 'stiffness' in the wall of the aorta. In this study, the investigators propose to 1.) study aortic size, stiffness and flow patterns using MRI in patients with bicuspid and tricuspid valves with a narrowing (aortic stenosis, 2.) measure markers in patients' blood that may be important in the process of expansion, 3.) compare the change in MRI and blood markers at before and 12 months after surgery, in patients who are due to have aortic valve replacement surgery.
- Conditions
- Aortic Stenosis
- Being tested
- ECG, Blood test and biobanking, Trans-thoracic Echocardiogram, Vicorder recording, Magnetic Resonance Imaging
- Keywords
- Magnetic Resonance Imaging, Elastin Metabolites, Aorta Stiffness, Bicuspid aortic valve
- Medical subject headings
- Aortic Valve Stenosis, Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDiagnostic test
A 12-lead ECG will be taken for each participant.
Blood test and biobankingDiagnostic test
All patients will undergo venepuncture and blood sample will be taken for full blood count, renal function and plasma will be stored for future biomarker analysis.
Trans-thoracic EchocardiogramDiagnostic test
A standard TTE will be undertaken to measure severity of AS as well as bi-ventricular function. Speckle-tracking data will be performed offline to assess diastolic function.
Vicorder recordingDiagnostic test
Measurement of carotid-femoral PWV will be made using the Vicorder technique.
Magnetic Resonance ImagingDiagnostic test
Patients will undergo a stress MRI scan of their heart and aorta on a 3T scanner, including 4D flow.
| Study group | Role | What they receive |
|---|---|---|
| Bicuspid Aortic valve | Patients with a bicuspid aortic valve Receives: Diagnostic Test: ECG; Diagnostic Test: Blood test and biobanking; Diagnostic Test: Trans-thoracic Echocardiogram; Diagnostic Test: Vicorder recording; Diagnostic Test: Magnetic Resonance Imaging | |
| Tri-leaflet Aortic valve | Patients with a tri-leaflet aortic valve Receives: Diagnostic Test: ECG; Diagnostic Test: Blood test and biobanking; Diagnostic Test: Trans-thoracic Echocardiogram; Diagnostic Test: Vicorder recording; Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of metabolites of elastin turnover
Change in levels of metabolites of elastin turnover pre- and post-AVR.
Measured: 12 months
Secondary outcomes (4)
Aortic distensibility on MRI
Aortic distensibility measured on MRI pre- and post-AVR.
Measured: 12 months
Pulse wave velocity on MRI
Pulse wave velocity (measure of aortic stiffness) measured on MRI pre- and post-AVR.
Measured: 12 months
Left ventricular mass index (LVMI) on MRI
LVMI measured on MRI (measures of cardiac remodelling) pre- and post-AVR.
Measured: 12 months
Left ventricular ejection fraction (LVEF) on MRI
LVEF measured on MRI (measures of cardiac function) pre- and post-AVR.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start27 Jun 2019
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883490
- Sponsor's protocol ID
- 0687
- Acronym
- ELASTIC-AS
- Status last verified
- Dec 2023
- First submitted
- 11 Mar 2019
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No