Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03914248 |
Other study ID # |
E182026 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 1, 2019 |
Est. completion date |
January 26, 2022 |
Study information
Verified date |
May 2022 |
Source |
University of Edinburgh |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Large vessel vasculitis (LVV) causes blood vessel inflammation leading to pain, fatigue and
complications such as aneurysm formation and stroke. Treatments used can have significant
side-effects. Doctors find it difficult to determine when to start and stop treatment, often
leading to over- or under-treatment. A new test is required to determine disease activity
that will guide treatment more accurately. This study will recruit participants with active
LVV from throughout Scotland in order to assess the ability of two new types of scan -
positron emission tomography with magnetic resonance imaging (PET/MR) and retinal optical
coherence tomography (OCT) - to determine disease activity. In addition, I will investigate
the link between LVV and heart disease.
Description:
Large vessel vasculitis (LVV) is a multi-system, autoimmune disease characterised by
non-specific symptoms, pain and high glucocorticoid requirements. The lack of a robust
biomarker that tracks disease activity makes disease monitoring difficult. This leads to both
disease over-treatment, resulting in adverse effects of glucocorticoids, and under-treatment,
with the potential for significant vascular complications. Additionally, the link between LVV
and cardiovascular disease (CVD), which is the main cause of death in these patients, remains
poorly characterised. An imaging tool which is capable of accurately monitoring disease
activity over time is urgently required. Positron emission tomography with magnetic resonance
imaging (PET/MR) and retinal optical coherence tomography (OCT) have the potential to meet
this need. PET/MR is uniquely useful for imaging CVD and utilises ~50% of the radiation dose
of PET with computerised tomography. OCT is a novel potential biomarker of microvascular
dysfunction, systemic inflammation and CVD risk in small vessel vasculitis. Participants with
a new diagnosis or recent flare of LVV will undergo serial PET/MR and OCT scanning alongside
established measures of CVD risk. Results will be compared with current clinical measures of
disease activity and with banked control data.