Longitudinal Imaging in Patients With Large Vessel Vasculitis to Predict Further Disease Course

N/ACompletedNCT04204876

University Hospital, Basel, Switzerland40 enrolled

Overview

Longitudinal imaging in patients with large vessel vasculitis to predict further disease course

This explorative longitudinal prospective observational study is to explore different aspects of vessel wall characteristics as detected by magnet resonance imaging (MRI) techniques and positron emission tomography/computer tomography (PET/CT) in patients with large vessel giant cell Arteriitis (LV-GCA) for their usefulness as predictive factor for future giant cell arteritis (GCA) relapse. It analyses parameters in PET/CT and MRI in patients with GCA at treatment stop which correlate with GCA relapse within the first 6 months after treatment stop. Patients included in the established local GCA database (BARK) will be screened for eligibility. Aortal imaging is performed during routine care according to established guidelines at diagnosis and during Follow Up at least every two years and before treatment stop.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Giant Cell Arteritis Large Vessel Giant Cell Arteriitis

Interventions

Magnet Resonance Imaging (MRI)DIAGNOSTIC_TEST

MRI with and without Gadolinium contrast agent for the following vessels: thoracic aorta (ascending, arch, descending arch, left and right common carotic, subclavian, and vertebral artery)

PET/CT analysisDIAGNOSTIC_TEST

Standard value uptake measurement (SUV) based on quantitative score normalized to liver (SUV vessel max/liver mean) at the following vessel regions: Carotid artery: common, internal, external; Subclavian artery; Axillary artery; Vertebral artery; Thoracic Aorta; Abdominal Aorta; Common femoral artery; Deep femoral artery; Popliteal artery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed diagnosis of GCA and having a diagnosis of LV-GCA confirmed by imaging (PET/CT) * Informed consent to the local GCA cohort BARK * Followed for GCA treatment in the outpatient department. Exclusion Criteria: * Known hypersensitivity or allergy to Gadolinium (Gd)-based MRI contrast agents. * Patients with cardiac pacemakers, intra cranial clips, metallic foreign bodies or other not MR-compatible implants (e.g. pumps etc.). * Renal failure or severely impaired kidney function (eGFR \< 30 ml/min /1,73 m2) * Epilepsy.

Locations (1)

Department of Rheumatology, University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Change in mural thickening at MRI analysis

0 = no mural thickening (maximal vessel wall thickness \<2 mm for aorta, \<1mm for its branches) 1. = mural thickening (2-3 mm for aorta, 1-2 mm for its branches); 2. = strong thickening (\>3 mm for aorta, \>2mm for its branches)