NCT00893126已完成不适用
Premature Coronary Artery Disease (CAD) in Severe Psoriasis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To establish the relationship between psoriasis and coronary disease
研究概览
简要总结
The purpose of this study is to compare the prevalence and severity of CAD (coronary artery disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular risk factors.
详细描述
To establish the relationship between psoriasis and coronary disease by comparing the prevalence and severity of CAD (coronary artery disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular risk factors, as determined by CT coronary calcium scoring and Coronary CT angiography.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with severe psoriasis as determined by more than two episodes of systemic or inpatient treatment and 10% or more body surface area involvement.
- •Male or female ages 18 to 55 (because CAD risk has been shown to be greatest in younger psoriasis patients in earlier studies, this pilot study will focus on young individuals).
- •Able to give informed consent
排除标准
- •Prior diagnosis of CAD (coronary artery disease) or heart disease based upon one or more of the following:
- •coronary arteriography
- •percutaneous coronary intervention
- •cardiac surgery including bypass graft surgery
- •valve surgery
- •congenital heart disease repair
- •stress ECG or imaging
- •myocardial infarction
- •angina or unstable angina
- •congestive heart failure
- •cardiomyopathy
- •History of anti-oxidants such as fish oil or biologic therapy Tumor Necrosis Factor alpha inhibitors (such as etanercept, adalimumab, or infliximab). A recent review by Sattar et al [22] has shown preliminary evidence that TNF (tumor necrosis factor) blockade can modulate nontraditional cardiovascular risk factors such as C-reactive protein(CRP), Interleukin-6(IL-6), Apolipoprotein AI(ApoAI), Lipoprotein(a)(Lp[a]), Sex Hormone Binding Globulin (SHBG), and homocysteine to exert a possible vascular and metabolic protective effect.
- •Pustular and erythrogenic psoriasis
- •Unable to give informed consent
- •Contraindications to coronary CT, including:
- •Irregular heart rate, such as multiple PVCs (premature ventricular contractions), atrial fibrillation
- •Active heart failure
- •Serum creatinine > 1.5mg/dl
- •Weight > 320 lbs (due to degradation in CT (computerized tomography)image quality by image noise)
- •History of severe allergy to intravenous contrast media
- •High irregular heart rate with contraindications to beta-blockers
结局指标
主要结局
To establish the relationship between psoriasis and coronary disease
时间窗: 1 year
次要结局
未报告次要终点
研究者
Prachi P Agarwal, M.D.
Principal Investigator
University of Michigan
研究点 (1)
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