The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PET-CT.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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).
Interventions
- Radiation PET-CT
PET combined with CT or MRI
Primary outcome measures
- Haemodynamic aortic valve disease progression. [Time frame: 4 years]
Secondary outcome measures (1)
- Inflammatory, thrombotic, fibrotic and calcific aortic valve disease progression. [Time frame: 4 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- University of Edinburgh — Edinburgh
Identifiers
NCT: NCT06047561 · AC22131 · RG/F/22/110093