NCT06047561 The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme
| NCT ID | NCT06047561 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Aortic Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-05-22 |
| Primary Completion | 2028-05-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-05-22 with a primary completion date of 2028-05-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06047561 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06047561 currently recruiting?
Yes, NCT06047561 is actively recruiting participants. Contact the research team at neil.craig@ed.ac.uk for enrollment information.
Where is the NCT06047561 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT06047561 clinical trial?
NCT06047561 is sponsored by University of Edinburgh. The trial plans to enroll 300 participants.