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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06047561
Acronym
SALTIRE
Enrollment
300
Registered
2023-09-21
Start date
2023-05-22
Completion date
2028-05-22
Last updated
2025-09-17

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

Conditions

Aortic Stenosis

Keywords

Aortic Stenosis

Brief summary

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

RADIATIONPET-CT

PET combined with CT or MRI

Sponsors

University of Edinburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Haemodynamic aortic valve disease progression.4 yearsRate of change of maximal aortic valve jet velocity (AV Vmax)

Secondary

MeasureTime frameDescription
Inflammatory, thrombotic, fibrotic and calcific aortic valve disease progression.4 yearsRate of change of tissue-to-background ratio (TBRmax) of FDG, GP1, FAPI and NaF PET.

Countries

United Kingdom

Contacts

Primary ContactNeil Craig
neil.craig@ed.ac.uk07383558066
Backup ContactDavid Newby
d.e.newby@ed.ac.uk

Outcome results

None listed

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