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临床试验/NCT03946410
NCT03946410进行中(未招募)不适用

Danish Cardiovascular Screening Trial II

Odense University Hospital8 个研究点 分布在 1 个国家目标入组 38,000 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

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

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

Active Comparator

Invitation to cardiovascular screening

干预措施: Invitation to screening (Diagnostic Test)

Control

Placebo Comparator

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

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

Jes Lindholt

Professor of Vascular Surgery

Odense University Hospital

研究点 (8)

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