The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme

Study Overview
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Brief Summary
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The goal of this observational study is to understand the processes of what causes and accelerates the disease progress in aortic stenosis and following aortic valve replacement. Participants will undergo transthoracic echocardiography every 6 months, with annual visits for state-of-the-art scanning techniques including positron-emission tomography combined with computed tomography or magnetic resonance imaging with radiotracers designed to look at disease processes including fibrosis, calcification, inflammation and thrombosis activity.

Detailed Description
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This will be an observational cohort study using existing and prospectively recruited cohorts for both cross-sectional and longitudinal comparison across the spectrum of aortic stenosis severity. For existing cohorts of patients who have previously undergone research assessments, we will invite them for repeated assessments. Participants will be reviewed every 6 months in the Clinical Research Facility (CRF) over a 4-year period. They will undergo clinical assessment, blood sampling, transthoracic echocardiography and advanced imaging annually including CT angiography, magnetic resonance and positron emission tomography (PET).

Official Title
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The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Radiation: PET-CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged >50 years Provision of informed consent prior to any study specific procedures Patients with bioprosthetic aortic valve replacements, including both surgically and transcatheter implanted valves Patients with severe aortic stenosis (peak velocity >4.0 m/s; previously recruited patients) Patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s; new prospectively recruited patients) Patients with mild aortic stenosis (peak velocity 2.5-2.9 m/s; new prospectively recruited patients) Patients with aortic sclerosis (tri-leaflet thickened aortic valve with no obstruction of ventricular outflow) Age and sex-matched healthy volunteers Exclusion Criteria: Inability or unwilling to give informed consent. Those with an allergy to iodinated contrast Patients with impaired renal function (eGFR of <30 mL/min/1.73m2) Women who are pregnant or breastfeeding. Patients with known Rheumatic Heart Disease Patients with known Ochronosis Patients with known Familial Homozygous Hypercholesterolaemia

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aortic Stenosis<br>Participants with Aortic Stenosis across the spectrum of disease severity | Radiation: PET-CT<br>* PET combined with CT or MRI<br>* Other names: Positron Emission Tomography;|
| Aortic Valve Replacement<br>Participants who have previously undergone aortic valve replacement | Radiation: PET-CT<br>* PET combined with CT or MRI<br>* Other names: Positron Emission Tomography;|
| Healthy Volunteers<br>Healthy Volunteers for the purposes of case-control analysis | Radiation: PET-CT<br>* PET combined with CT or MRI<br>* Other names: Positron Emission Tomography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamic aortic valve disease progression. | Rate of change of maximal aortic valve jet velocity (AV Vmax) | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory, thrombotic, fibrotic and calcific aortic valve disease progression. | Rate of change of tissue-to-background ratio (TBRmax) of FDG, GP1, FAPI and NaF PET. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Stenosis