1. Validate and adjust the current classification criteria for systemic vasculitis2. Develop and validate new diagnostic criteria for systemic vasculitis
ID
Source
Brief title
Condition
- Autoimmune disorders
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
See above
1. Model of criteria who can best classiffy patients with vasculitis into
different vasculitis subgroups.
2. Model of criteria who can beste distinguish patients with vasculitis from
the vasculitis mimic patients
Secondary outcome
n.a.
Background summary
Primary systemic vasculitides are auto-immune vessel wall inflammatory diseases
and have an annual incidence of more than 100 new cases per million persons.
All types of blood vessels can be involved and the clinical effects of
vasculitis are therefore diverse. Today, these illnesses are classified
according to the size of vessels involved (large, median, small), the type of
inflammation observed in a biopsy (granulomatous, eosinophilic, etc.) and
certain clinical characteristics like headache, age, renal involvement, etc.
These classification criteria were developed in 1993. Classification criteria
assume the presence of vasculitis and subsequently help categorize these
vasculitides in different groups. Classification criteria in itself are not
capable to distinguish vasculitis patients from patients without vasculitis. In
order to achieve this diagnostic criteria are needed. At the moment there are
no validated diagnostic criteria available for systemic vasculitis.
The availability of well validated diagnostic criteria will help clinicians
diagnose patients earlier and with more accuracy. It can be expected that
patients can then be treated more quickly and more efficiently. The chance of
developing damage due to the disease will be reduced. Well developed diagnostic
criteria also help better distinguish patients with vasculitis from those who
have complaints who look like vasculitis (the *vasculitis mimics*). The latter
group requires different treatment.
Study objective
1. Validate and adjust the current classification criteria for systemic
vasculitis
2. Develop and validate new diagnostic criteria for systemic vasculitis
Study design
Include patients with vasculitis and patients with other diseases who can mimic
vasculitis. The available clinical, serological, pathological and radiological
parameters will be recorded and analyzed. A multivariate analysis model will be
developed who can identify the key factors distinguishing the various diseases.
As part of this process, we will develop a series of vignettes based on
different cases of which a group of international experts judges that they fit
a certain type of vasculitis best. In this process existing classification
criteria will be validated and possibly new criteria will be developed.
Moreover, diagnostic criteria will be developed who best distinguish vasculitis
patients from non-vasculitis patients (vasculitis mimics).
Study burden and risks
Twice extra time investment during an already planned hospital visit. (60
minutes total). Within this visit patients will be asked questions and if
applicable be physically investigated. Extra blood will be drawn coupled to the
already planned blood withdrawal.
Department of Orthopaedics Rheumatology and Musculoskeletal Science, Botnar Research Centre, University of Oxford, Windmill Road,
Oxford, UK. OX3 7LD
GB
Department of Orthopaedics Rheumatology and Musculoskeletal Science, Botnar Research Centre, University of Oxford, Windmill Road,
Oxford, UK. OX3 7LD
GB
Listed location countries
Age
Inclusion criteria
• Adult patients aged >=18 years. There is no upper age limit.
• Ability to give informed consent.
• New presentation or an established diagnosis of Wegener's granulomatosis, microscopic polyangiitis, Churg Strauss syndrome, giant cell arteritis, Takayasu arteritis, other primary large vessel vasculitis or complaints that mimic these diseases.
Exclusion criteria
• Patients < 18 years of age
• Patient unwilling or unable to provide informed consent.
• Known co morbidity at time of presentation that explains the clinical presentation.
• Hepatitis B or C
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01066208 |
| CCMO | NL32107.042.10 |