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Role of Elastin Metabolites in Aortic Remodelling in AS

A Pilot Study of ELastin Metabolites and Aortic Remodelling Following Surgery for Tricuspid and bICuspid Aortic Stenosis (ELASTIC-AS)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03883490
Acronym
ELASTIC-AS
Enrollment
46
Registered
2019-03-21
Start date
2019-06-27
Completion date
2023-08-31
Last updated
2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

Magnetic Resonance Imaging, Elastin Metabolites, Aorta Stiffness, Bicuspid aortic valve

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTVicorder recording

Measurement of carotid-femoral PWV will be made using the Vicorder technique.

DIAGNOSTIC_TESTECG

A 12-lead ECG will be taken for each participant.

DIAGNOSTIC_TESTBlood test and biobanking

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.

DIAGNOSTIC_TESTTrans-thoracic Echocardiogram

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.

DIAGNOSTIC_TESTMagnetic Resonance Imaging

Patients will undergo a stress MRI scan of their heart and aorta on a 3T scanner, including 4D flow.

Sponsors

University of Leicester
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Levels of metabolites of elastin turnover12 monthsChange in levels of metabolites of elastin turnover pre- and post-AVR.

Secondary

MeasureTime frameDescription
Pulse wave velocity on MRI12 monthsPulse wave velocity (measure of aortic stiffness) measured on MRI pre- and post-AVR.
Aortic distensibility on MRI12 monthsAortic distensibility measured on MRI pre- and post-AVR.
Left ventricular mass index (LVMI) on MRI12 monthsLVMI measured on MRI (measures of cardiac remodelling) pre- and post-AVR.
Left ventricular ejection fraction (LVEF) on MRI12 monthsLVEF measured on MRI (measures of cardiac function) pre- and post-AVR.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026