Subclinical Impairment of Cardiovascular System in Patients With Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Arterial function - arterial stiffness
研究概览
简要总结
A cross-sectional study will be conducted, which will include 80 young patients with psoriasis, aged 30-45 years, treated with five different types of antipsoriatic treatment, and 20 healthy patients. All 100 subjects will be subjected to anthropometric measurements, blood will be collected for laboratory tests, and an imaging test will be performed to determine the function of the endothelium and arterial stiffness. The results will then be statistically analyzed.
详细描述
Research design: A cross-sectional study will be conducted, which will include 80 young patients with psoriasis, aged 30-45 years, without other chronic diseases, treated with five different types of treatment (local therapy, methotrexate, inhibitor of tumor necrosis factor α, inhibitor of interleukin 17 and inhibitor of interleukin 23), and 20 healthy patients aged 30-45 years. All 100 subjects will be subjected to anthropometric measurements (measurement of weight, height, systolic and diastolic blood pressure, heart rate, waist circumference), blood will be collected for laboratory tests (full blood count with differential, CRP, serum electrolytes, lipid panel, fasting glucose, HbA1c, alanine aminotransferase, aspartate aminotransferase, creatinine, urea, TNF-alpha, IL-6, IL-12, IL-17, IL-23, hsCRP, IFN-gamma, TRANCE, TRAIL, GDF-15, D-dimer, fibrinogen, overall haemostasis potential, overall coagulation potential, VCAM-1, ECAMs), and an imaging test (flow-mediated dilation and measurement of pulse wave velocity) will be performed to determine the function of the endothelium and arterial stiffness. The results will then be statistically analyzed.
Aim of the study: The impact of chronic systemic inflammation in psoriasis on subclinical defects in the cardiovascular system (endothelial dysfunction, arterial stiffness, insulin resistance, platelet activation, and coagulation activation) and their effects on each other will be studied. In addition, the effect of the five main types of psoriasis treatment on all listed subclinical defects of the cardiovascular system will be investigated. Moreover, it will be investigated whether the type of treatment affects systemic inflammation in psoriasis in the same manner.
Expected results: It is expected that all five groups of patients will differ from each other in terms of the degree of subclinical impairment of the cardiovascular system, depending on the expression of psoriasis and the type of treatment they receive. This will form the basis for establishing preventive measures against cardiovascular diseases in patients with psoriasis.
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
- 30 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with psoriasis aged 30 to 45 years in stable phase of the disease for at least last 6 months
排除标准
- •any treatment besides treatment of psoriasis
- •carotid disease
- •heart failure
- •atrial fibrillation
- •diabetes type 1 or 2
- •cardiovascular event in the past
- •chronic kidney disease stage 3, 4, 5 or end-stage kidney disease
- •psoriatic arthritis or any other rheumatic disease
- •malignancy
- •menopause in women
- •other chronic inflammatory diseases
结局指标
主要结局
Arterial function - arterial stiffness
时间窗: through study completion, an average of 6 months
Arterial stiffness (pulse wave velocity)
Endothelial activation
时间窗: through study completion, an average of 6 months
Circulating markers of endothelial activation (E-selectin, vascular cell adhesion molecule-1 (VCAM-1), Endothelial cell adhesion molecules (ECAMs))
Arterial function - endothelial function
时间窗: through study completion, an average of 6 months
Endothelial function (flow-mediated dilation)
次要结局
- Inflammation(through study completion, an average of 6 months)
- Insulin resistance(through study completion, an average of 6 months)
- Activation of coagulation(through study completion, an average of 6 months)
- Platelet activation (2)(through study completion, an average of 6 months)
- Metabolic disturbances(through study completion, an average of 6 months)
- Activation of hemostasis(through study completion, an average of 6 months)
- Coagulation(through study completion, an average of 6 months)
- Metabolic disturbances - dyslipidemia(through study completion, an average of 6 months)
- Liver steatosis(through study completion, an average of 6 months)
- Platelet activation (1)(through study completion, an average of 6 months)
研究者
Eva Klara Merzel Šabović
Eva Klara Merzel Šabović, MD
University Medical Centre Ljubljana