Subclinical Cardiovascular Disease in Psoriatic Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript
研究概览
简要总结
This study will look at how chronic inflammation seen in psoriatic disease translates into the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk. The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic disease and measures of vascular function. 2) Evaluate the association between moderate to severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional medications used in cardiovascular disease (CVD) prevention such as aspirin and statins affect vascular function and thrombotic risk in those with moderate to severe psoriatic disease.
详细描述
Cardiovascular disease (CVD) remains the leading cause of death in the US. Five modifiable risk factors: smoking, hyperlipidemia, diabetes, hypertension and obesity, account for 50% of CVD mortality between the ages of 45 - 79.1 These traditional cardiac risk factors dictate who to treat with primary prevention measures but do not take into account patient-specific disease states such as psoriatic disease including psoriasis and psoriatic arthritis, which predispose to chronic inflammation. Patients with psoriatic disease have an increased risk of atherosclerotic heart disease and myocardial infarctions compared to matched controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with a history of moderate to severe psoriatic disease
- •Group 2: Healthy subjects without known psoriatic disease or cardiovascular disease
排除标准
- •Unable to speak Spanish or English
- •Active smoking (within the past year)
- •Autoimmune, rheumatologic or inflammatory disease which are not psoriasis or psoriatic arthritis
- •Known active cancer receiving treatment
- •Pregnancy
- •Anemia (hemoglobin < 9 mg/dl) or thrombocytopenia (Platelet count <75), or thrombocytosis (Platelet count >600)
- •A history of severe bleeding or bleeding disorders
- •Current medication use which interact with either aspirin or atorvastatin
- •Chronic kidney disease (CrCl < 30ml/min)
- •Congestive heart failure
- •Currently taking aspirin or a statin.
- •NSAID use within the past 48 hours
研究组 & 干预措施
Psoriatic Disease Patients
Moderate to severe psoriatic disease
干预措施: Aspirin and/or Atorvastatin (Drug)
结局指标
主要结局
Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript
时间窗: Baseline, 5 Months
Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation
次要结局
- Fold Change Change in Composite Endothelial Inflammation(Baseline (pre-Aspirin), 2 weeks (post-Aspirin))
- Fold Change in Composite Endothelial Inflammation(Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin))
- Change in Levels of Circulating Thromboxane B2(Baseline (pre-Aspirin), 2 weeks (post-Aspirin))