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Monitoring Large Vessel Vasculitis With PET/MR Imaging

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ClinicalTrials.gov Identifier: NCT03914248
Recruitment Status : Recruiting
First Posted : April 15, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

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.

Condition or disease
Large Vessel Vasculitis

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring Large Vessel Vasculitis With PET/MR Imaging: an Exploratory Study
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis

Group/Cohort
Active large vessel vasculitis
PET/MR scan



Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Blood and urine


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from outpatient clinics throughout Scotland
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914248


Contacts
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Contact: Neeraj Dhaun, MBChB PhD 01312429215 bean.dhaun@ed.ac.uk

Locations
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United Kingdom
University of Edinburgh Recruiting
Edinburgh, United Kingdom, EH164TJ
Contact: Neeraj Dhaun, MBChB         
Sponsors and Collaborators
University of Edinburgh
Investigators
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Principal Investigator: Neeraj Dhaun, MBChB PhD University of Edinburgh

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03914248     History of Changes
Other Study ID Numbers: E182026
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vasculitis
Vascular Diseases
Cardiovascular Diseases