MedPath

ailfold videocapillaroscopy in juvenile (systemic) autoimmune diseases

Recruiting
Conditions
autoimmunity
lupus
Raynaud
10003816
10023213
10047066
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
Inclusion Criteria

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/+

Exclusion Criteria

Lack of written informed consent

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<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
NameTimeMethod
<p>not applicable</p><br>
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