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

Recruiting

• Conditions: Aortic Stenosis
• Interventions: Radiation: PET-CT

• Registration Number: NCT06047561
• Lead Sponsor: University of Edinburgh

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).

Study Timeline

• Study Start: 2023-05-22
• Study First Submitted: 2023-08-18
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-14
• Last Update Submitted: 2023-09-14
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2028-05-22
• Study Completion: 2028-05-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	PET-CT	Healthy Volunteers for the purposes of case-control analysis
Aortic Stenosis	PET-CT	Participants with Aortic Stenosis across the spectrum of disease severity
Aortic Valve Replacement	PET-CT	Participants who have previously undergone aortic valve replacement

Primary Outcome Measures

Name	Time	Method
Haemodynamic aortic valve disease progression.	4 years	Rate of change of maximal aortic valve jet velocity (AV Vmax)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Edinburgh; 🇬🇧 Edinburgh, United Kingdom