Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
Study NCT ID:
NCT06047561
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2023-08-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-05-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2023-09-14', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Haemodynamic aortic valve disease progression.', 'timeFrame': '4 years', 'description': 'Rate of change of maximal aortic valve jet velocity (AV Vmax)'}], 'secondaryOutcomes': [{'measure': 'Inflammatory, thrombotic, fibrotic and calcific aortic valve disease progression.', 'timeFrame': '4 years', 'description': 'Rate of change of tissue-to-background ratio (TBRmax) of FDG, GP1, FAPI and NaF PET.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic Stenosis'], 'conditions': ['Aortic Stenosis']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants 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.', 'detailedDescription': '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.\n\nParticipants 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged \\>50 years\n* Provision of informed consent prior to any study specific procedures\n* Patients with bioprosthetic aortic valve replacements, including both surgically and transcatheter implanted valves\n* Patients with severe aortic stenosis (peak velocity \\>4.0 m/s; previously recruited patients)\n* Patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s; new prospectively recruited patients)\n* Patients with mild aortic stenosis (peak velocity 2.5-2.9 m/s; new prospectively recruited patients)\n* Patients with aortic sclerosis (tri-leaflet thickened aortic valve with no obstruction of ventricular outflow)\n* Age and sex-matched healthy volunteers\n\nExclusion Criteria:\n\n* Inability or unwilling to give informed consent.\n* Those with an allergy to iodinated contrast\n* Patients with impaired renal function (eGFR of \\<30 mL/min/1.73m2)\n* Women who are pregnant or breastfeeding.\n* Patients with known Rheumatic Heart Disease\n* Patients with known Ochronosis\n* Patients with known Familial Homozygous Hypercholesterolaemia'}, 'identificationModule': {'nctId': 'NCT06047561', 'acronym': 'SALTIRE', 'briefTitle': 'The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme', 'orgStudyIdInfo': {'id': 'AC22131'}, 'secondaryIdInfos': [{'id': 'RG/F/22/110093', 'type': 'OTHER_GRANT', 'domain': 'British Heart Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aortic Stenosis', 'description': 'Participants with Aortic Stenosis across the spectrum of disease severity', 'interventionNames': ['Radiation: PET-CT']}, {'label': 'Aortic Valve Replacement', 'description': 'Participants who have previously undergone aortic valve replacement', 'interventionNames': ['Radiation: PET-CT']}, {'label': 'Healthy Volunteers', 'description': 'Healthy Volunteers for the purposes of case-control analysis', 'interventionNames': ['Radiation: PET-CT']}], 'interventions': [{'name': 'PET-CT', 'type': 'RADIATION', 'otherNames': ['Positron Emission Tomography'], 'description': 'PET combined with CT or MRI', 'armGroupLabels': ['Aortic Stenosis', 'Aortic Valve Replacement', 'Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SB', 'city': 'Edinburgh', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Neil Craig', 'role': 'CONTACT', 'email': 'neil.craig@ed.ac.uk', 'phone': '07383558066'}, {'name': 'Neil Craig', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'centralContacts': [{'name': 'Neil Craig', 'role': 'CONTACT', 'email': 'neil.craig@ed.ac.uk', 'phone': '07383558066'}, {'name': 'David Newby', 'role': 'CONTACT', 'email': 'd.e.newby@ed.ac.uk'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'End of Study to 15 years', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}