ailfold videocapillaroscopy in juvenile (systemic) autoimmune diseases
- Conditions
- autoimmunitylupusRaynaud100038161002321310047066
- Registration Number
- NL-OMON50708
- Lead Sponsor
- Emma Kinderziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
1. Healthy children, 6-18 years old2. Pediatric patients < 18 years old, with
one of the following diagnoses:
- Systemic lupus erythematosus (SLE), according to Systemic Lupus International
Collaborating Clinics (SLICC) criteria
- Systemic sclerosis (SSc), according to EULAR criteria
- lokalized scleroderma (lSc), differentiated from SSc by the absence of
sclerodactyly, RP, nailfold capillary changes, and organ involvement
- Juvenile dermatomyositis (JDM), according to Bohan and Peter criteria
- Juvenile idiopathic arthritis (JIA), according to the International League of
Associations for Rheumatology (ILAR) criteria
- Kawasaki disease (KD), according to the 5th revision of diagnostic criteria
- Raynaud's phenomenon (RP), diagnostic questions as described by Wigley3.
Adult patients >=18 years old, with a diagnosis childhood-onset SLE / RP,
diagnosed before the age of 18#*¶*l/+
Lack of written informed consent
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>NVC measurements consist of describing the following variables per 1 mm image<br /><br>(4 images per finger, digits 2-5 on both sides):<br /><br>- Density: number of capillaries per mm (mean 9, range 6-12)<br /><br>- Abnormal shapes described as not-hairpin/tortuous/crossing (1)<br /><br>- Capillary apex maximum diameter (20-50 mcm described as enlarged, >50mcm<br /><br>described as giant capillary)<br /><br>- Large micro-hemorrhages (pathological bleedings with apical cap-like<br /><br>appearance)<br /><br>- Small multiple point-shaped hemorrhages surrounding the capillary loop<br /><br>(extravasations)<br /><br><br /><br>Specific endpoint for study 3: diagnosis of a (systemic) autoimmune disease.</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>