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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

Tracking Information
First Submitted Date August 18, 2023
First Posted Date September 21, 2023
Last Update Posted Date September 21, 2023
Actual Study Start Date May 22, 2023
Estimated Primary Completion Date May 22, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 14, 2023)		 Haemodynamic aortic valve disease progression. [ Time Frame: 4 years ]
Rate of change of maximal aortic valve jet velocity (AV Vmax)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 14, 2023)		 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme
Official Title The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Aortic Stenosis
Intervention Radiation: PET-CT
PET combined with CT or MRI
Other Name: Positron Emission Tomography
Study Groups/Cohorts
  • Aortic Stenosis
    Participants with Aortic Stenosis across the spectrum of disease severity
    Intervention: Radiation: PET-CT
  • Aortic Valve Replacement
    Participants who have previously undergone aortic valve replacement
    Intervention: Radiation: PET-CT
  • Healthy Volunteers
    Healthy Volunteers for the purposes of case-control analysis
    Intervention: Radiation: PET-CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 14, 2023)		 300
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 22, 2028
Estimated Primary Completion Date May 22, 2028   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Neil Craig 07383558066 neil.craig@ed.ac.uk
Contact: David Newby d.e.newby@ed.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT06047561
Other Study ID Numbers AC22131
RG/F/22/110093 ( Other Grant/Funding Number: British Heart Foundation )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: End of Study to 15 years
Current Responsible Party University of Edinburgh
Original Responsible Party Same as current
Current Study Sponsor University of Edinburgh
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Edinburgh
Verification Date September 2023