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临床试验/NCT06287125
NCT06287125尚未招募不适用

Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients

Assiut University0 个研究点目标入组 95 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
95
主要终点
Evaluate Multiparametric MRI in SSC and SLE

研究概览

简要总结

  • Evaluate renal resistive index in SSc and SLE patients for early detection of renal impairment.
  • Evaluate renal multi-parametric MRI in SSc and SLE patients for early detection of renal impairment.
  • Measure the serum levels of CD147 in SSc and SLE patients and its correlation with renal impairment.
  • Correlation between detected markers and other assessment tools.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (aged above 18 years) SSc patients who fulfilled the 2013 European League Against Rheumatism/American College of Rheumatology (EULAR / ACR) for SSC [13] and 1980 ACR criteria [14].
  • Adult SLE Patients who fulfilled the 2019 EULAR / ACR classification criteria for systemic lupus erythematosus [15]

排除标准

  • Individuals with other autoimmune diseases.
  • Infections as chest infection, hepatitis C, hepatitis B and HIV infection.
  • Tumors as hepatocellular carcinoma.
  • Hypertension, diabetes, heart failure, hepatic diseases, chronic renal failure, intrarenal arteriovenous fistula, obstructive nephropathy and urinary tract obstruction.
  • Contraindication for MRI as implanted metallic devices.

结局指标

主要结局

Evaluate Multiparametric MRI in SSC and SLE

时间窗: One year

It's correlation with renal impairment

Evaluate renal resistive index in SSC and SLE patients

时间窗: One year

It's correlation with renal impairment

Evaluate serum levels of CD147 in SSc and SLE patients

时间窗: One year

Its correlation with renal impairment

次要结局

  • Utility of Multiparametric MRI in SSC and SLE(One year)
  • Utility of renal resistive index in SSC and SLE patients(One year)
  • Utility of CD 147 in ssc and SLE patients(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Nabil Badr

assistant lecturer

Assiut University

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