Danish Cardiovascular Screening Trial II
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 38,000
- 试验地点
- 8
- 主要终点
- Overall mortality
研究概览
简要总结
This study attempts to reduce social inequality in cardiovascular health by performing an interventional screening trial on how best to decrease cardiovascular disease (CVD) among people with low social status.
详细描述
Background
Although CVDs have decreased, they are still among the most predominant cause of morbidity and mortality in the western world, incl. Denmark, where about 420,000 people have recognized CVD symptoms. Due to an aging population, the decline has not reduced CVD admissions and healthcare costs. In Denmark, the CVD related hospital admission costs are DKK 4.6 billion and the pharmaceutical cost DKK 2.4 billion. The Danish National Board of Health has reported that CVD carries the second largest socioeconomic difference in burden of disease. Unfortunately, population-based health checks and screening for risk factors has proven not efficient. Consequently, screening of asymptomatic CVD is discussed intensively. In the investigators first unique CVD screening RCT (2008-11), the Viborg Vascular (VIVA) trial, more than 50.000 65-74 year old men were randomised for population-based ultrasound screening for abdominal aortic aneurysm (AAA), peripheral arterial disease (PAD) and hypertension. In case of positive finding, preventive medical actions were initiated. A significant reduction in overall mortality by 7% after 5 years was observed. Using a non-contrast computered tomography (CT) scan, instead of the ultrasound based screening approach, has the opportunity to identify aneurysms in the entire aortic, coronary artery calcification (CAC) and arterial fibrillation, so individualized risk assessment and initiation of preventive actions on those with sign of early asymptomatic CVD is possible. A second trial - The Danish Cardiovascular Screening (DANCAVAS) trial initiated was initiated in 2014 randomizing 45.000 65-74 year old men with the potential of a huge beneficial effect on health, quality of life (QoL) and survival. However, screening is impaired by lower social class, and adherence to initiated prevention could be impacted as well. Consequently, we want to conduct a third RCT (Fighting Social Inequality in Cardiovascular Health (FISICH) to test a number of add-ons to screening that potentially balance the benefits across socio economic groups. The perspective is to establish a clear decision foundation for public health care policy incl. benefits, cost effectiveness and impact on social inequality of alternative variants of population screening for CVD.
Hypotheses
The primary hypothesis is that an extensive circulatory screening and intervention programme reduces social inequality in cardiovascular health and fulfills the WHO criteria for screening. However, this reduction can be even more pronounced, if factors reducing the social selection to attend screening and adherence to preventive actions initiated are identified.
Aims
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 64 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 60-64 living in the municipalities of Funen, Silkeborg, Vejle and surrounding municipailties
排除标准
- •Men not aged 60-64
- •Men not living in the mentioned municipalities
研究组 & 干预措施
Screening
Invitation to cardiovascular screening
干预措施: Invitation to screening (Diagnostic Test)
Control
No invitation to cardiovascular screening
干预措施: Invitation to screening (Diagnostic Test)
结局指标
主要结局
Overall mortality
时间窗: 5 years
Deaths of any cause
次要结局
未报告次要终点
研究者
Jes Lindholt
Professor of Vascular Surgery
Odense University Hospital
