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

Aortic Stenosis Clinical Trial

— SALTIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047561
• Other study ID #: AC22131
• Secondary ID: RG/F/22/110093
• Status: Recruiting
• Start date: May 22, 2023
• Est. completion date: May 22, 2028

Study information

• Verified date: September 2023
• Source: University of Edinburgh
• Contact: Neil Craig
• Phone: 07383558066
• Email: neil.craig[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 22, 2028
• Est. primary completion date: May 22, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Radiation:
• PET-CT
PET combined with CT or MRI

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemodynamic aortic valve disease progression.	Rate of change of maximal aortic valve jet velocity (AV Vmax)	4 years
Secondary	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