Observational Study on Cardiac Morphology and Function in Patients With Peripheral Artery Disease in Vastmanland County, Sweden(PADVa).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 457
- 试验地点
- 1
- 主要终点
- Left ventricular ejection fraction (cross-sectional outcome measure)
研究概览
简要总结
The main purposes of this study are:
- to describe the prevalence and degree of reduced left ventricular function and hypertrophy in patients with peripheral arterial disease in comparison to controls from the general population,
- to evaluate factors of importance to left ventricular dysfunction and hypertrophy in patients with peripheral arterial disease, and
- to assess the impact of cardiac function and left ventricular hypertrophy on long-term prognosis in patients with peripheral artery disease.
详细描述
Left ventricular dysfunction is often a consequence of coronary heart disease (CHD). CHD is prevalent among patients with peripheral artery disease. However, there is limited data regarding left ventricular morphology and function in those patients. In the cross-sectional part of this study we will describe the prevalence of reduced cardiac function and left ventricular hypertrophy in a cohort of patients with peripheral artery disease. The patient outcomes will be compared to control subjects randomly selected from the general population in a case-control design. Further, clinical and genetic determinants of cardiac dysfunction in the patient cohort will be identified. In the longitudinal part of the study, the impact of cardiac function and morphology on cardiovascular mortality and morbidity will be evaluated in the cohort.
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
- •Fulfillment of at least one of the following criteria:
- •ankle-brachial-index (ABI) <= 0.9, or
- •stenosis of > 30% of the internal carotid artery, or
- •symptoms typical for claudication and corresponding stenotic findings on the ultrasound examination.
排除标准
- •age less than 18 years
- •severly impaired communication capabilities
结局指标
主要结局
Left ventricular ejection fraction (cross-sectional outcome measure)
时间窗: baseline
LVEF obtained by echocardiographic biplane disk summation method. In the cross-sectional study, the mean value of LVEF and the prevalence of reduced LVEF (LVEF \< 50%) in the patient group will be compared to the control group.
Cardiovascular events (longitudinal outcome measure)
时间窗: 5-10 years
Cardiovascular events obtained from the Swedish National Causes of Death register and the Swedish National In-patient register. The registers are linked to the patients by the unique personal identification number assigned to each swedish resident.
Left ventricular mass (cross-sectional outcome measure)
时间窗: baseline
Left ventricular mass obtained by 2-dimensional echocardiography according to the American Society of Echocardiography.
次要结局
- Wall motion score index (WMSI)(baseline)
- Echocardiographic left ventricular filling variables(baseline)