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

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ClinicalTrials.gov Identifier: NCT06047561
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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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.


Condition or disease Intervention/treatment
Aortic Stenosis 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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme
Actual Study Start Date : May 22, 2023
Estimated Primary Completion Date : May 22, 2028
Estimated Study Completion Date : May 22, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: Positron Emission Tomography
Aortic Valve Replacement
Participants who have previously undergone aortic valve replacement
 Radiation: PET-CT
PET combined with CT or MRI
Other Name: Positron Emission Tomography
Healthy Volunteers
Healthy Volunteers for the purposes of case-control analysis
 Radiation: PET-CT
PET combined with CT or MRI
Other Name: Positron Emission Tomography


Outcome Measures
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Primary Outcome Measures :
  1. Haemodynamic aortic valve disease progression. [ Time Frame: 4 years ]
    Rate of change of maximal aortic valve jet velocity (AV Vmax)


Secondary Outcome Measures :
  1. Inflammatory, thrombotic, fibrotic and calcific aortic valve disease progression. [ Time Frame: 4 years ]
    Rate of change of tissue-to-background ratio (TBRmax) of FDG, GP1, FAPI and NaF PET.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06047561


Contacts
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Contact: Neil Craig 07383558066 neil.craig@ed.ac.uk
Contact: David Newby d.e.newby@ed.ac.uk

Locations
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United Kingdom
University of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SB
Contact: Neil Craig    07383558066    neil.craig@ed.ac.uk   
Principal Investigator: Neil Craig         
Sponsors and Collaborators
University of Edinburgh
More Information
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT06047561    
Other Study ID Numbers: AC22131
RG/F/22/110093 ( Other Grant/Funding Number: British Heart Foundation )
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: End of Study to 15 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Edinburgh:
Aortic Stenosis
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction