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NCT Number: NCT06047561

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

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.

Recruiting

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Edinburgh

Edinburgh, EH16 4SB, United Kingdom

Location status: Recruiting

Location contact

Neil Craig

CONTACT

[email protected]

07383558066

Neil Craig

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET-CT

Radiation

PET combined with CT or MRI

Other names: Positron Emission Tomography

Primary outcomes

  1. Haemodynamic aortic valve disease progression.

    Time frame: 4 years

    Rate of change of maximal aortic valve jet velocity (AV Vmax)

Secondary outcomes

  1. Inflammatory, thrombotic, fibrotic and calcific aortic valve disease progression.

    Time frame: 4 years

    Rate of change of tissue-to-background ratio (TBRmax) of FDG, GP1, FAPI and NaF PET.

Study contacts

Contact information is provided by the study sponsor or research team.

David Newby

CONTACT

[email protected]

Neil Craig

CONTACT

[email protected]

07383558066

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Acronym: SALTIRE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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