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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Radiation: PET-CT

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Neil Craig; Phone Number: 07383558066; Email: neil.craig@ed.ac.uk
• Study Contact Backup: Name: David Newby; Email: d.e.newby@ed.ac.uk

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SB
    • Recruiting
    • University of Edinburgh
    • Contact: Neil Craig; Phone Number: 07383558066; Email: neil.craig@ed.ac.uk
    • Principal Investigator: Neil Craig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

We will recruit up to 300 patients with aortic valve disease across the spectrum of disease severities from aortic sclerosis through to mild, moderate and severe aortic stenosis as defined by the European Society of Cardiology. We will also include those who have undergone bioprosthetic aortic valve replacement, and age and sex-matched control subjects with normal aortic valves.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aortic Stenosis; Participants with Aortic Stenosis across the spectrum of disease severity	Radiation: PET-CT; PET combined with CT or MRI; Other Names: Positron Emission Tomography
Aortic Valve Replacement; Participants who have previously undergone aortic valve replacement	Radiation: PET-CT; PET combined with CT or MRI; Other Names: Positron Emission Tomography
Healthy Volunteers; Healthy Volunteers for the purposes of case-control analysis	Radiation: PET-CT; PET combined with CT or MRI; Other Names: Positron Emission Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemodynamic aortic valve disease progression.	Rate of change of maximal aortic valve jet velocity (AV Vmax)	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Estimated): May 22, 2028
• Study Completion (Estimated): May 22, 2028

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Aortic Stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: AC22131; RG/F/22/110093 (Other Grant/Funding Number: British Heart Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: End of Study to 15 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No