NCT05775354Enrolling By Invitation不适用
Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- UMC Utrecht
- 入组人数
- 1,476
- 试验地点
- 2
- 主要终点
- Coronary artery disease
研究概览
简要总结
The goal of this randomized trial is to compare the diagnostic yield of a screen-like early diagnosis strategy to usual primary care to detect coronary artery disease (CAD), atrial fibrillation (AF), heart failure (HF), and/or valvular heart disease (VHD) in community people aged 50-80 years who participate in the Utrecht Health Project.
The diagnosis strategy consists of a questionnaire with questions related to symptoms suggestive of CAD, AF or HF, a focused physical examination, laboratory testing, electrocardiography, and echocardiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50-80 years
- •Being a participant of LRGP
- •Having indicated in the LRGP informed consent to be interested in participating in further research.
排除标准
- •Diagnosed with coronary artery disease and atrial fibrillation and heart failure.
- •Undergoing major (cardiovascular) surgery, and/or revascularisation therapy and/or transplantation treatment within 3 months after enrolment.
- •Not willing to give written informed consent for RED-LRGP.
- •Not allowing incidental findings to be reported to him/herself or their own GP.
结局指标
主要结局
Coronary artery disease
时间窗: 1 year
Atrial fibrillation
时间窗: 1 year
Heart failure
时间窗: 1 year
Valvular heart disease
时间窗: 1 year
次要结局
- CVD family history and women's reproductive history(1 year)
- Echocardiographic abnormalities(1 year)
- Health-related quality of life(1 year)
- Cardiovascular risk profile(1 year)
- Costs(1 year)
研究者
研究点 (2)
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