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Role of Elastin Metabolites in Aortic Remodelling in AS (ELASTIC-AS)

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ClinicalTrials.gov Identifier: NCT03883490
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Leicester

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.

Condition or disease Intervention/treatment
Aortic Stenosis Diagnostic Test: ECG Diagnostic Test: Blood test and biobanking Diagnostic Test: Trans-thoracic Echocardiogram Diagnostic Test: Vicorder recording Diagnostic Test: Magnetic Resonance Imaging

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of ELastin Metabolites and Aortic Remodelling Following Surgery for Tricuspid and bICuspid Aortic Stenosis (ELASTIC-AS)
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 21, 2020
Estimated Study Completion Date : August 21, 2020


Group/Cohort Intervention/treatment
Bicuspid Aortic valve
Patients with a bicuspid aortic valve
Diagnostic Test: ECG
A 12-lead ECG will be taken for each participant.

Diagnostic Test: Blood 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 Test: Trans-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 Test: Vicorder recording
Measurement of carotid-femoral PWV will be made using the Vicorder technique.

Diagnostic Test: Magnetic Resonance Imaging
Patients will undergo a stress MRI scan of their heart and aorta on a 3T scanner, including 4D flow.

Tri-leaflet Aortic valve
Patients with a tri-leaflet aortic valve
Diagnostic Test: ECG
A 12-lead ECG will be taken for each participant.

Diagnostic Test: Blood 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 Test: Trans-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 Test: Vicorder recording
Measurement of carotid-femoral PWV will be made using the Vicorder technique.

Diagnostic Test: Magnetic Resonance Imaging
Patients will undergo a stress MRI scan of their heart and aorta on a 3T scanner, including 4D flow.




Primary Outcome Measures :
  1. Levels of metabolites of elastin turnover [ Time Frame: 12 months ]
    Change in levels of metabolites of elastin turnover pre- and post-AVR.


Secondary Outcome Measures :
  1. Aortic distensibility on MRI [ Time Frame: 12 months ]
    Aortic distensibility measured on MRI pre- and post-AVR.

  2. Pulse wave velocity on MRI [ Time Frame: 12 months ]
    Pulse wave velocity (measure of aortic stiffness) measured on MRI pre- and post-AVR.

  3. Left ventricular mass index (LVMI) on MRI [ Time Frame: 12 months ]
    LVMI measured on MRI (measures of cardiac remodelling) pre- and post-AVR.

  4. Left ventricular ejection fraction (LVEF) on MRI [ Time Frame: 12 months ]
    LVEF measured on MRI (measures of cardiac function) pre- and post-AVR.


Biospecimen Retention:   Samples Without DNA
Patient's plasma will be collected and stored for measurement of elastin metabolites and other biomarkers.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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.

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): NCT03883490


Contacts
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Contact: Anvesha Singh, MBChB, PhD +44 1162583244 as707@le.ac.uk

Sponsors and Collaborators
University of Leicester

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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03883490     History of Changes
Other Study ID Numbers: UOL0687
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
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 University of Leicester:
Magnetic Resonance Imaging
Elastin Metabolites
Aorta Stiffness
Bicuspid aortic valve

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction