At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- PET-CT (radiation)
- How long the study runs
- Study runs about 60 months (dates as stated)
- About the drug or intervention
- PET-CT — radiation: PET combined with CT or MRI
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 50 Years and over
- Who
- All
- Number of participants
- 300
- Started
- 2023-05-22
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for aortic stenosis
- • Clinical study - 300 participants
- • 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
Who can take part?
- • Ages 50 Years and over
- • Diagnosed with aortic stenosis
Where?
- • Edinburgh - University of Edinburgh
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Male or female aged \>50 years
- ✓Provision of agreement to take part 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)
Who cannot take part
- ✗Inability or unwilling to give agreement to take part.
- ✗Those with an allergy to iodinated contrast
- ✗Patients with impaired kidney function (eGFR of \<30 mL/min/1.73m2)
- ✗Women who are pregnant or breastfeeding.
- ✗Patients with known Rheumatic Heart Disease
See the full criteria
Where Is This Study? (1 UK site)
University of Edinburgh
Edinburgh EH16 4SB, United Kingdom
How to Get in Touch
Neil Craig
Sponsor contactCONTACT
David Newby
Sponsor contactCONTACT