Long-term follow-up of aortal adverse events, as well as glucocortioid-associated adverse events in patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA).
In this non-interventional cohort study the following aspects should be addressed: * Can regular imaging procedures help to better assess the risk of aortic aneurysms and dissections over a period of 5-10 years after initial diagnosis of GCA? * Which prognostic factors correlate with aortic events? * What conclusions can be drawn about glucocorticoid-associated side effects over the longer (5-year) course? * Can modern imaging in correlation with standardized clinical examination, serological markers and immunophenotypic testing define patient clusters within the clinically heterogeneous disease spectrum of GCA and PMR with the aim of individualizing therapy? * What is the value of orbital MRI together with an ophthalmologic examination including fudoscopy and optical coherence tomography (OCT) in the detection of ischemic manifestations of GCA? * Can a contrast agent-saving MRI technique (with 25 % less contrast agent) be used in GCA without impairing signal quality? * Can rare lymphocyte populations be found by immunophenotyping, which provide information on the probability of recurrence or allow therapy control?
Study Type
OBSERVATIONAL
Enrollment
400
Universitätsklinikum Würzburg
Würzburg, Germany
RECRUITINGIncidence of aortic adverse events
Aortic adverse events include new foramation or progress of aortic aneurysms, and aortic dissection
Time frame: Within 5 years
Incidence of glucocorticoid-related adverse events
Assessment of the glucocorticoid toxicity index (GTI; excluding regular bone density measurements) to detect glucocorticoid-related adverse events. The GIT includes 1) a cumulative worsening score, which includes the cumulative glucocorticoid toxicity over time (minimum value of 0 and a maximum value of 439, a decrease is not possible) and 2) an aggregate improvement score, which allows for decreases and increases of toxicity (range from -346 to 439, with negative values indicating improvement and positive values indicating worsening of glucocorticoid toxicity)
Time frame: within 5 years
Detection of ischemic complications in the eyes
Is orbital MRI together with optic coherence tomography suitable to detect ischemic manifestations of GCA in the eye?
Time frame: within 5 years
Performance of gadopiclenol in detecting vessel wall inflammation
The contrast agent gadopiclenol should be evaluated for its use in MR angiography, i.e. if it depicts (peri) vessel wall inflammation equally to older contrast agents. In a sub-cohort of 20 % of the patients , MR angiographies will be performed with 25% reduced gadoplicenol.
Time frame: within 5 years
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