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临床试验/NCT03946956
NCT03946956已完成不适用

Fighting Social Inequality in Cardiovascular Health I

Odense University Hospital10 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,000
试验地点
10
主要终点
Attendance rate to screening

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 VIVA trial, they randomized more than 50.000 65-74 year old men 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 (paper submitted). Using a non-contrast 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. The investigators therefore initiated a second trial (DANCAVAS) 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, they want to conduct a third RCT (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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Screening
盲法
None

入排标准

年龄范围
60 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

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 60-65
  • Men not living in the mentioned municipalities

结局指标

主要结局

Attendance rate to screening

时间窗: 6 months

The proportion of invited attending screening

次要结局

  • Quality of Life of invitation to screening(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jes Lindholt

Professor

Odense University Hospital

研究点 (10)

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