Monitoring Large Vessel Vasculitis With PET/MR Imaging
1 other identifier
observational
27
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2022
CompletedMay 24, 2022
May 1, 2022
2.6 years
April 2, 2019
May 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum standardised uptake values (SUVmax)
Maximum standardised uptake values (SUVmax) will be assessed using PETMR. This information will be used to quantify disease activity and atheroma at pre-specified vascular segments.
0 and 6 months
Secondary Outcomes (5)
Choroidal thickness in microns
0 and 6 months
Choroidal volume in mm3
0 and 6 months
Retinal vasculature morphology
0 and 6 months
24-hour ambulatory blood pressure in mmHg
0 and 6 months
Pulse wave velocity
0 and 6 months
Study Arms (1)
Active large vessel vasculitis
PET/MR scan
Eligibility Criteria
Participants will be recruited from outpatient clinics throughout Scotland
You may qualify if:
- A new diagnosis of LVV or a known diagnosis of LVV presenting with disease relapse
You may not qualify if:
- Predominantly cranial symptoms
- LVV secondary to other conditions
- Treatment with high dose glucocorticoids for \>2 weeks at time of recruitment
- Contraindication to MR or PET
- Unable to travel to Edinburgh
- Estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m2
- Unable to provide informed consent
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Edinburgh
Edinburgh, EH164TJ, United Kingdom
Biospecimen
Blood and urine
Study Officials
- PRINCIPAL INVESTIGATOR
Neeraj Dhaun, MBChB PhD
University of Edinburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2019
First Posted
April 16, 2019
Study Start
July 1, 2019
Primary Completion
January 26, 2022
Study Completion
January 26, 2022
Last Updated
May 24, 2022
Record last verified: 2022-05