An observational study in Systemic Lupus Erythematosus, sponsored by ASST Gaetano Pini-CTO. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by ASST Gaetano Pini-CTO · Observational
The purpose of this study is to investigate the role of nailfold capillaroscopy in the assessment of patients with Systemic Lupus Erythematosus (SLE).
Primary endpoint:
Secondary endpoints:
Background and rationale:
Nailfold capillaroscopy (NC) is a diagnostic investigation used in the routine clinical setting for the differential diagnosis of connective tissue diseases, such as Systemic Lupus Erythematosus (SLE). Among SLE clinical manifestations, vascular involvement is a common feature and a variable prevalence of NC abnormalities has been reported in SLE: typical NC changes, as well as non-specific variations as observed in healthy subjects.
At this very moment literature is interspersed with different descriptions of capillaroscopic features in SLE, and it has not been clearly defined the role of NC in SLE patients. It has been suggested that the presence of major capillary abnormalities may reflect the microvascular systemic involvement in SLE, and it may correlate to the disease activity.
Against this background, the EULAR study group on microcirculation in rheumatic diseases planned an international multicenter study.
Objective:
To investigate the role of NC abnormalities in the assessment of SLE patients.
Endpoints:
Primary endpoint:
-To compare the frequency of major capillary abnormalities in patients with SLE and healthy controls.
Secondary endpoints:
No. of subjects:
Total entered: 364 ; Cases (SLE): 182 ; Controls: 182.
Variables
NC assessment: presence of major capillary abnormalities; NC parameters/mm: number of capillaries, presence of hairpin, tortuous, crossed, bushy, ramified, enlarged, giant capillaries, microhemorrhages, architecture disorganization, visibility of the subpapillary venular plexus; presence of scleroderma patterns, normal patterns.
Clinical assessment: all subjects: date of birth, gender, race. SLE: age at disease onset, disease activity (SLEDAI-2000) and damage index (SLICC-DI), presence of antinuclear antibodies, anti-dsDNA, anti-Extractable Nuclear Antigen antibodies, lupus anticoagulant, anticardiolipin/beta2glycoprotein I antibodies, Raynaud's phenomenon, Hypertension, active smoke, diabetes mellitus, ongoing and cumulative dose steroid treatment, ongoing immunomodulatory/suppressive treatment.
Statistical methods For the primary endpoint and similar secondary endpoints, McNemar test (matching design) and a conditional odds ratio (OR). For other secondary endpoints, the Fisher's exact test and an OR, and a conditional logistic regression model (matching design) and non-conditional regression model and OR as appropriate.
patients ≥18 years diagnosed with SLE upon classification according to 2012 SLICC criteria and disease onset ≥16 years.
Exclusion Criteria:
patients ≥18 years diagnosed SLE upon classification according to 2012 SLICC criteria and disease onset ≥16 years.
Device: nailfold capillaroscopy
subjects ≥18 years fulfilling the definition proposed in the protocol.
Device: nailfold capillaroscopy
Detection by nailfold capillaroscopy of capillary abnormalities in patients with Systemic Lupus Erythematosus and comparison with healthy controls at enrolment
major capillary abnormalities
To compare the frequency of major capillary abnormalities in patients with SLE and healthy controls.
Time frame: Day 1
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
ASST Gaetano Pini-CTO