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临床试验/NCT04891783
NCT04891783Unknown不适用

Investigating Atherosclerosis In Seronegative Spondyloarthropathy

Sohag University0 个研究点目标入组 120 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
主要终点
Investigate the presence of atherosclerosis in two diseases of seronegative spondyloarthropathy ankylosing spondylitis and psoriatic arthritis patients

研究概览

简要总结

The association between inflammation and atherosclerosis is widely known. An increase in morbidity and mortality due to cardiovascular (CV) disease in inflammatory rheumatic diseases has been proved [1-4]. Rheumatoid arthritis (RA) has the greatest CV impact. Scientific societies and expert groups have developed recommendations for preventing cardiovascular risk in these patients [5, 6]. It has also been observed an increased CV risk and greater morbidity in other inflammatory rheumatic diseases such as Ankylosing Spondylitis (AS), psoriatic arthritis (PsA), and inflammatory bowel disease(IBD) [1, 7n, 8].

Ankylosing spondylitis (AS) is a systemic inflammatory disorder of unknown etiology that mainly involves the axial skeleton causing the spine, sacroiliac joints arthritis, and peripheral joints arthritis. Its peak age of onset is between 20-30 years affecting young males with the involvement of extra-articular structures such as eyes, kidneys, heart, lung, vessels, and nerves [9,10]. Aortitis and aortic regurgitation are cardiovascular complications associated with AS. AS is associated with up to 50% mortality rates and cardiovascular diseases are the main causes of these high mortality rates[10,11].

详细描述

The association between inflammation and atherosclerosis is widely known. An increase in morbidity and mortality due to cardiovascular (CV) disease in inflammatory rheumatic diseases has been proved . Rheumatoid arthritis (RA) has the greatest CV impact. Scientific societies and expert groups have developed recommendations for preventing cardiovascular risk in these patients . It has also been observed an increased CV risk and greater morbidity in other inflammatory rheumatic diseases such as Ankylosing Spondylitis (AS), psoriatic arthritis (PsA), and inflammatory bowel disease(IBD).

Ankylosing spondylitis (AS) is a systemic inflammatory disorder of unknown etiology that mainly involves the axial skeleton causing the spine, sacroiliac joints arthritis, and peripheral joints arthritis. Its peak age of onset is between 20-30 years affecting young males with the involvement of extra-articular structures such as eyes, kidneys, heart, lung, vessels, and nerves [9,10]. Aortitis and aortic regurgitation are cardiovascular complications associated with AS. AS is associated with up to 50% mortality rates and cardiovascular diseases are the main causes of these high mortality rates.

The psoriatic disease concept includes psoriatic arthritis (PsA). PsA is a chronic inflammatory skeletal disease associated with psoriasis. PsA has heterogeneous clinical manifestations with some forms linked to the spondyloarthritis(SpA) concept. A strong relationship of PsA with SpA is clearly supported by shared clinical, genetic, and radiographic characteristics.

CV comorbidities are critically important in this patient population because they may directly contribute to increased mortality seen in patients PsA.

Sustained chronic systemic inflammation predisposes to atherosclerosis as it is accompanied by elevated levels of serum C-reactive protein (CRP), which has proatherogenic effects. Also, hypertension, sex, and smoking are predisposing factors with chronic inflammation in atherosclerosis.3 Moreover, AS has been associated with a prevalence of metabolic syndrome including dyslipidemia and a high ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol .

研究设计

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

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age at disease onset above 16 yrs old
  • Patients diagnosed as according to 1984 modified New York criteria of AS .including radiographic and non-radiographic AS according to ASAS crteriae[22].
  • Psoriatic arthritis patients fulfilling the diagnostic criteria defined by the Classification Criteria of Psoriatic Arthritis (CASPAR[23]study and with a diagnosis confirmed by a rheumatologist

排除标准

  • Diabetes mellitus or use of antidiabetic medication.
  • Heart failure, as defined by ejection fraction <50%.
  • Renal disease.
  • Chronic obstructive lung disease; pulmonary hypertension; pregnancy or obesity.
  • Metabolic syndrome.
  • History of cardiovascular, peripheral artery disease, or cerebrovascular events.

结局指标

主要结局

Investigate the presence of atherosclerosis in two diseases of seronegative spondyloarthropathy ankylosing spondylitis and psoriatic arthritis patients

时间窗: 2 years

The purpose of this study is to investigate the presence of atherosclerosis based on the results of carotid ultrasound and serum irsin level in two diseases of seronegative spondyloarthropathy ankylosing spondylitis and psoriatic arthritis patients.

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

Salma Mohamed Shabaan

assistant lecturer

Sohag University

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