An observational study in Systemic Sclerosis and Systemic Lupus Erythematous, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Assiut University · Observational
Systemic sclerosis (SSc) is an autoimmune disease characterized by endothelial dysfunction, collagen deposition, and fibrosis in the skin and internal organs. Systemic lupus erythematosus (SLE) is a complex, multi-organ autoimmune disease. The presence of autoantibodies and circulating immune complexes can cause vasculitis and damage the endothelial cells, leading to multiple organ dysfunctions. Renal involvement in SSc, ranges from urinary abnormalities, reduction of glomerular filtration rate (GFR), and high resistive indices, to scleroderma renal crisis (SRC). Subclinical renal vasculopathy is characterized by progressive increase of intrarenal stiffness and reduction of parenchymal thickness due to post ischemic fibrosis secondary to the renal Raynaud phenomenon.Conversely, in SLE-related kidney manifestations, renal damage results from glomerular involve-ment secondary to immune-complex acti¬vation. Cluster of differentiation 147 (CD147) is, also named extracellular matrix metalloproteinase inducer (EMMPRIN), a transmembrane glycoprotein in the immunoglobulin superfamily that is widely expressed on the surface membrane of various cells. Higher levels of soluble CD147 were found in SSc patients compared to healthy controls and higher levels in SSc patients with scleroderma renal crisis (SRC). Suggesting that CD147 could be a useful tool for identifying SRC risk. In patients with active SLE, CD147 is overexpressed on CD3 T lymphocytes. Renal resistive index (RRI) is a useful non-invasive technique for evaluation of renal disease activity in SLE patients. It can differentiate between patients with active lupus nephritis (LN) and inactive LN. RRI was higher in SSc patients than other autoimmune diseases since subclinical renal vasculopathy is the main pathogenic mecha¬nism of all SSc renal manifestations.Multiparametric renal Magnetic Resonance Imaging (MRI) shows great promise as a non-invasive method to assess kidney structure and function without exposure to radiation or gadolinium contrast agents. In MRI microstructural changes of lupus nephritis kidney such as inflammatory cell infiltration or fibrosis could influence water molecular movement or diffusion, which indicates that diffusion-weigted imaging (DWI) may become a valuable tool in diagnosis of LN. However in systemic sclerosis there is decline of renal blood flow values that indicate microvascular pathology.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 95 is below the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The study will include adult SSc and SLE patients consecutively presented at the rheumatology, rehabilitation and physical medicine department, Assiut university hospital from both inpatient department and outpatient clinic
Exclusion Criteria:
Adult (aged above 18 years) SSc patients who fulfilled the 2013 European League Against Rheumatism/American College of Rheumatology (EULAR / ACR) for SSC and 1980 ACR criteria. -SSc patients will be subjected to 2017 European Scleroderma Trials and Research group (EUSTAR) activity index
Device: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147
Adult SLE Patients who fulfilled the 2019 EULAR / ACR classification criteria for systemic lupus erythematosus. -SLE patients will be subjected to SLE Disease Activity Score (SLE-DAS).
Device: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147
Apparently healthy subjects
Device: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147
Laboratory investigations: erythrocyte sedimentation rate (ESR) Serum C-reactive protein (CRP) complete blood picture (CBC) liver function tests (LFT): aspartate transaminase (AST), alanine transaminase (ALT), serum albumin, serum bilirubin. kidney function tests (KFT): serum creatinine and blood urea. Estimated glomerular filteration rate (eGFR) by CKD-EPI Creatinine Equation (2021). Complete urine analysis for: proteinuria, urinary casts (hyaline, granular), hematuria (RBCs/ high power field), pyuria (WBCs/ high power field). 24 hour protein in urine and Creatinine clearance. Complement 3and 4(C3,C4). Immunological investigations : Antinuclear antibody (ANA) and Anti-double stranded DNA (ds-DNA). Serum CD147 Radiological investigations: * Chest X-ray * Renal Doppler * Multi-parametric MRI
Evaluate serum levels of CD147 in SSc and SLE patients
Its correlation with renal impairment
Time frame: One year
Evaluate renal resistive index in SSC and SLE patients
It's correlation with renal impairment
Time frame: One year
Evaluate Multiparametric MRI in SSC and SLE
It's correlation with renal impairment
Time frame: One year
Utility of CD 147 in ssc and SLE patients
for early detection of renal impairment inandSLE patients
Time frame: One year
Utility of renal resistive index in SSC and SLE patients
For early detection of renal impairment
Time frame: One year
Utility of Multiparametric MRI in SSC and SLE
For early detection of renal impairment
Time frame: One year
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Lupus Erythematosus, Systemic→
Assiut University