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临床试验/NCT05479071
NCT05479071Unknown不适用

Relation of Antibodies Against Oxidized Low Density Lipoproteins to Disease Activit y and Cardiovascular Affection in Systemic Lupus.

Assiut University0 个研究点目标入组 100 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
主要终点
Checking level of oxidized LDL.

研究概览

简要总结

The aim of this study is to correlate the autoantibody against oxidized LDL with disease activity and cardiovascular affection in patients with SLE.

详细描述

Systemic lupus erythematosus (SLE) is an autoimmune inflammatory disease affecting mainly women of fertile age. It is characterized by hyperactivity of B-cells and by overproduction of autoantibodies without organ specificity, many of which contribute to the formation of immunocomplexes. Their deposition in tissues and blood vessels results in inflammatory organ impairment (Khairy et al., 2017). As for the laboratory findings in SLE, production of autoantibodies without organ specificity aimed at nuclear, cytoplasmic, and surface antigens of the patient's body is typical. The most common SLE manifestations include involvement of skin, joints, cardiovascular system, lungs, renal glomeruli, central nervous system or hematopoiesis.

SLE can result in failure of the involved organs, severe forms of SLE thus bein gassociated with significant mortality (Pashnina et al., 2021).

Cardiovascular involvement is associated with increased morbidity and mortality of SLE patients. The most common SLE-related cardiovascular events are myocardial infarctions (MIs), cerebrovascular events, thromboembolic events (TEs), heart failure, and sudden death.

Cardiovascular events are proportionally higher in SLE compared to general populations of comparable age and sex (Ramirez et al., 2020). The pathogenic mechanisms of different cardiac diseases in SLE are still incompletely understood. Traditional risk factors for Cardiovascular affection, such as older age, high blood pressure (BP), high cholesterol and triglycerides, smoking, obesity, diabetes mellitus, and - last but not least - SLE therapy all play a critical role. These factors alone cannot adequately explain the increased incidence of cardiovascular disease commonly reported in patients with SLE. Metabolic syndrome was considered a remarkable risk factor for the development of subclinical atherosclerosis and increased carotid intima-media thickness The non-traditional biomarkers included both leptin and homocysteine, where leptin acts on the immune system as aproinflammatory cytokine. It promotes the proliferation and activation of T lymphocytes and induces production of Th1 cytokines. Homocysteinelevels have been identified as a predictor of atherosclerosis in patients with SLE, in whom high levels may be predictive levels of coronary calcification, platelet progression and increased IMT (Khairy et al., 2017).

Specific antibodies cause oxidation of low density lipoprotein (LDL) particles, thus accentuating their atherogenic effect, or exert a negative influence on the character of physiologically protective High density lipoprotein (HDL) particles. Endothelial dysfunction within the vascular system ensues, increasing its vulnerability, affinity to lipoproteins and activity of enzymes accelerating the development of atherosclerosis (Li et al., 2020).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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
是

入选标准

  • •Patients aged ≥ 18 years.
  • •Patients fulfilling the American College of Rheumatology (ACE) criteria for SLE (Aringer et al., 2019).
  • •Patients diagnosed with SLE and without cardiovascular disease (CVD) impairment before the diagnosis of SLE was established.

排除标准

  • •Patients aged less than18 years.
  • •Patients not fulfilling the American College of Rheumatology (ACE) criteria for SLE (Aringer et al., 2019).

研究组 & 干预措施

SLE patients WITH cardiovascular disease

Relation of antibodies against LDL to disease activity in pt with cardiovascular disease

干预措施: Blood test (Diagnostic Test)

SLE Patients without cardiovascular disease

Relation of antibodies against LDL to disease activity in pt without cardiovascular disease

干预措施: Blood test (Diagnostic Test)

结局指标

主要结局

Checking level of oxidized LDL.

时间窗: Baseline

We expect that oxidized LDL is increasing in patient with SLE and those patients will be at risk for cardiovascular disaeses.

次要结局

未报告次要终点

研究者

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

HADDEEL AHMED MOHMED SAYED AHMED

Dr

Assiut University

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