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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-22

Study Completion Date

2028-05-22

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aortic Stenosis

Participants with Aortic Stenosis across the spectrum of disease severity

PET-CT

Intervention Type RADIATION

PET combined with CT or MRI

Aortic Valve Replacement

Participants who have previously undergone aortic valve replacement

PET-CT

Intervention Type RADIATION

PET combined with CT or MRI

Healthy Volunteers

Healthy Volunteers for the purposes of case-control analysis

PET-CT

Intervention Type RADIATION

PET combined with CT or MRI

Interventions

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PET-CT

PET combined with CT or MRI

Intervention Type RADIATION

Other Intervention Names

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Positron Emission Tomography

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes