Giant Cell Arteritis - Ways to Precision Medicine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Giant Cell Arteritis, Polymyalgia Rheumatic (PMR). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Riesenzellarteriitis - Wege Zur "Precision Medicine"
Overview
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).
Detailed description
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?
Primary outcome measures
- Incidence of aortic adverse events [Time frame: Within 5 years]
Secondary outcome measures (3)
- Incidence of glucocorticoid-related adverse events [Time frame: within 5 years]
- Detection of ischemic complications in the eyes [Time frame: within 5 years]
- Performance of gadopiclenol in detecting vessel wall inflammation [Time frame: within 5 years]
Eligibility criteria
Inclusion criteria
- Age greater or similar to 18 years
- Primary diagnosis of GCA or PMR
Exclusion criteria
- Age under 18 years
- lack of capacity to consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Universitätsklinikum Würzburg — Würzburg
Identifiers
NCT: NCT07084480 · Riesenzellarteriitis-Register