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OpenTrials
Completed

NCT Number: NCT03914248

Monitoring Large Vessel Vasculitis With PET/MR Imaging

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Edinburgh

Edinburgh, EH164TJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A new diagnosis of LVV or a known diagnosis of LVV presenting with disease relapse

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Maximum standardised uptake values (SUVmax)

    Time frame: 0 and 6 months

    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.

Secondary outcomes

  1. Choroidal thickness in microns

    Time frame: 0 and 6 months

    Assessment of choroidal thickness as measured using optical coherence tomography will be made at baseline and 6 months

  2. Choroidal volume in mm3

    Time frame: 0 and 6 months

    Assessment of choroidal volume using optical coherence tomography will be made at baseline and 6 months

  3. Retinal vasculature morphology

    Time frame: 0 and 6 months

    Visual assessment of arteriolar thickness, branching coefficient and branching angle, fractal dimension, and venular tortuosity will be made using OPTOS imaging at baseline and 6 months

  4. 24-hour ambulatory blood pressure in mmHg

    Time frame: 0 and 6 months

    Assessment of 24-hour ambulatory systolic and diastolic blood pressure will be made at baseline and 6 months

  5. Pulse wave velocity

    Time frame: 0 and 6 months

    Assessment of arterial stiffness will be made using pulse wave velocity as measured using SphygmoCor technology. Percentage change in pulse wave velocity will be compared between baseline and 6 months

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

Monitoring Large Vessel Vasculitis With PET/MR Imaging: an Exploratory Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 16, 2019
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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