Prevalence Study of Cardiovascular Diseases in a Population ≥ 65 Years in Italy
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
- VALVOLAR HEART DISEASE PREVALENCE
研究概览
简要总结
This registry is a large-scale epidemiological study (PREVASC) aimed at estimating the prevalence of symptomatic and asymptomatic valvular hear disease in men and women aged over 65 years randomly selected in Italy.
详细描述
PREVASC is a cross-sectional, population-based study. Participating subjects are invited from the general population and underwent a physical examination and an electrocardiography and echocardiographic examination by a local cardiologist. A random sample of about 2000 subjects over 65 years will be considered for sampling. The sample size is determined on the basis of a priori criteria in order to estimate a prevalence of 3% [standard error (SE) ± 1.1] for VHD.
Both clinical and demographic information will be collected to better characterize the invited population. Written informed consent for the clinical examination will be asked.
Demographic variables, cardiovascular (CV) risk, clinical history, physical findings, and medications will be recorded in a Case Report Form (CRF) by physicians or trained nurses. Assessment of anthropometric measures, blood pressure, and heart rate will be performed according to MONICA recommendations. Overweight is defined as a body mass index (BMI) between 25 and 29.9 kg/m2. Obesity is defined as BMI ≥30 kg/m2. Symptoms and signs attributable to VHD will be evaluated and reported on the CRF by a dedicated expert physician in each site at the time of the physical examination.
Echocardiography Complete Colour Doppler echocardiography will be performed in peripheral centers using commercially available machines according to a pre-defined protocol. Echocardiograms will be recorded in standard DICOM format on digital.
The following parameters will be acquired:
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subject ≥ 65 years with no history of previous valvular heart disease
排除标准
- •Age <65 years
- •Any acute disease
- •Recent hospitalization (until 1 month).
结局指标
主要结局
VALVOLAR HEART DISEASE PREVALENCE
时间窗: at baseline
The aim is to estimate the prevalence of symptomatic and asymptomatic valvolar heart disease in men and women aged over 65 years randomly selected in Italy: a complete colour-Doppler echocardiography will be performed in peripheral centres using commercially available machines according to a pre-defined protocol. Echocardiograms will be recorded with standard DICOM format on digital
次要结局
- BURDEN OF ATRIAL FIBRILLATION(baseline)
- LEFT VENTRICOLAR DIMENSIONS AND FUNCTION(at baseline)