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

ConditionAortic Stenosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age50+

SponsorUniversity of Edinburgh

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

PET-CT
Radiation
PET combined with CT or MRI

Treatment groups

300 Participants

are divided into 3 treatment groups

Group A: Aortic Stenosis1 intervention

Group B: Aortic Valve Replacement1 intervention

Group C: Healthy Volunteers1 intervention

Trial outcomes

Primary outcomes

Haemodynamic aortic valve disease progression.

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

Time frame

4 years

Secondary outcomes

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.

Time frame

4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Edinburgh

Lead sponsor

Source ClinicalTrials.gov

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