NCT00769275已完成不适用
Detection of Ischemia in Asymptomatic Diabetics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,123
- 试验地点
- 1
- 主要终点
- Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%.
研究概览
简要总结
Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5 years for the occurrence of cardiac death or non-fatal myocardial infarction.
The aims are:
- To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with Type 2 Diabetes Mellitus.
- To identify on the basis of clinical and/or biochemical variables in a high-risk cohort in which screening for coronary artery disease is appropriate.
- To assess progression of (silent) myocardial ischemia after 3 years.
- To assess the occurence of cardiac death or nonfatal myocardial infarction during 5 years follow-up in screened and not screened subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-75 years
- •Type 2 diabetes mellitus
排除标准
- •Angina or anginal equivalent
- •Abnormal rest ECG (Q or ST depression)
- •Known CAD
- •Stress testing within the last 3 years
结局指标
主要结局
Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%.
时间窗: At study entry
Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort
时间窗: 5 years
At repeat stress imaging three years after recruitment 79% of subjects showed resolution of ischemia, whereas only 10% developed new ischemia.
时间窗: 3 years after start
次要结局
未报告次要终点
研究者
研究点 (1)
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