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

Sponsor
University of Edinburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT06047561
Collaborator
(none)
300
Enrollment
1
Location
60
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated 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
Anticipated Primary Completion Date :
May 22, 2028
Anticipated Study Completion Date :
May 22, 2028

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Haemodynamic aortic valve disease progression. [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. [4 years]

      Rate of change of tissue-to-background ratio (TBRmax) of FDG, GP1, FAPI and NaF PET.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of Edinburgh Edinburgh United Kingdom EH16 4SB

    Sponsors and Collaborators

    • University of Edinburgh

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Edinburgh
    ClinicalTrials.gov Identifier:
    NCT06047561
    Other Study ID Numbers:
    • AC22131
    • RG/F/22/110093
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Aortic Valve Stenosis
    Constriction, Pathologic

    Study Results

    No Results Posted as of Sep 21, 2023