PSOCADIA: Prevalence and Risk Factors asSOciated With CArdiac comorbiDIty in psoriAsis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Cardiovascular mortality
研究概览
简要总结
In a prospective cohort study (n = 1.000), the investigators aim to investigate the correlation between cardiac biomarkers and advanced echocardiography and determine whether these are prognostic markers of heart disease in patients suffering from psoriasis.
详细描述
Cardiovascular disease (CVD) is mainly caused by atherosclerosis, now considered as a chronic inflammatory disease of blood vessels. Likewise, psoriasis is a chronic and relapsing, inflammatory, immune mediated disease. Atherosclerosis and psoriasis therefore share several pathophysiological traits. Previous epidemiological studies have demonstrated a high prevalence of cardiovascular (CV) risk factors in psoriasis patients, including metabolic syndrome, cigarette smoking, obesity, hypertension, diabetes mellitus, insulin resistance and dyslipidemia(1-11). Furthermore, studies suggest that psoriasis may be an independent risk factor for cardiovascular disease such as myocardial infarction(12-15), coronary artery disease(9, 16, 17), stroke(18-20) and cardiovascular mortality(18, 21, 22). In addition, psoriasis is associated with surrogate markers of cardiovascular disease and increased platelet activity, e.g. endothelial dysfunction and coronary calcification.
The fundamental role of inflammation in cardiovascular disease has prompted interest in the predictive capability of numerous biomarkers such as hsCRP, hsTNT, suPAR and pro-BNP that detect subclinical levels of inflammation. Hence, these inflammatory biomarkers might be able to reveal a pro-inflammatory disease state that represent a significant risk of CVD. Likewise, novel myocardial deformation imaging echocardiography, such as Tissue Doppler Imaging (TDI) and 2-dimensional speckle tracking echocardiography (2DSE), have been able to demonstrate subtle signs of myocardial dysfunction in high risk persons from the general population despite a normal convention echocardiography(24-26). These advanced echocardiographic techniques are able to detect asymptomatic reduced left ventricular function, which is not visible by the naked eye. Early identification of this group of patients is of utmost importance in order to initiate appropriate treatment in attempt to minimize further left ventricular damage and ensure better quality of life.
By evaluating biomarkers and advanced echocardiography in a prospective study setting it might be possible to establish the prevalence of cardiac dysfunction and disease in patients with psoriasis and to identify patients who have miniscule signs of cardiac dysfunction and therefore are in high risk of future fulminant cardiovascular disease.
Population
PSOCADIA is a prospective cohort study consisting of a random sample of 1.000 consecutive patients from a population of outpatients with psoriasis and a control group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years or older with a diagnosis of psoriasis will be invited to participate
排除标准
- •Patients not able to cooperate to the study
- •Patients unable understand and sign informed consent
研究组 & 干预措施
Psoriasis patients
Eligible psoriasis patients will be identified from the daily outpatient program, at the Department of Dermato-Allergology, that is the department will provide the patient's contact information to the project group. As most outpatient clinic psoriasis is classified as moderate to severe, in order to approximate a random sample as accurate as possible including patients with mild psoriasis, all people with a diagnosis of psoriasis will a general invitation to participate in the study through appropriate channels such as the Danish Psoriasis Foundation's newsletter.
干预措施: Psoriasis patients
Control group
The control group will consist of a retrospective random sample of around 1.000 patients from the general population examined in the 4th and 5th Copenhagen City Heart Study, 2001-2003 and 2011-2014 (ClinicalTrials.gov identifier NCT02993172, I-Suite no. 03741, National Committee on Health Research Ethics approval HEH-2015-045). Existing data from the Copenhagen City Heart Study will be transferred to the current study and will include personal identification number from the Central Office of Civil Registration, echocardiographic assessments, electrocardiograms as well as health related data (health conditions including symptoms, risk factors for cardiovascular disease, medication, prior clinical and/or paraclinical assessments including blood test results and procedures relevant to psoriasis and potential heart disease).
干预措施: Control group
结局指标
主要结局
Cardiovascular mortality
时间窗: 10 year follow-up
Coronary revascularization
时间窗: 10 year follow up
Percutaneous coronary intervention or coronary artery bypass graft
Myocardial infarction
时间窗: 10 year follow up
次要结局
- Admission with cardiac heart failure (CHF)(10 year follow up)
- Admission with stroke(10 year follow up)
- All-cause mortality(10 year follow up)
研究者
Maria Flarup Dons
MD, fellow
Herlev and Gentofte Hospital
