Randomized Strategy Trial Comparing Detection of Silent Ischemia With no Detection of Silent Ischemia in Asymptomatic Patients With Type 2 Diabetes Mellitus. Effects on Cardiovascular Events.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 642
- 试验地点
- 2
- 主要终点
- Death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention, measured after a minimum follow-up of 2 years
研究概览
简要总结
DYNAMIT is a prospective, randomized, multicenter, open strategy trial run in 45 French hospitals. Diabetic patients with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors are randomized to screening for silent ischemia using a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N=316), or follow-up without screening (N=315). All have access to cardiovascular prevention according current guidelines. The main end point is time to death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention.
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
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 55 to 75 years old had type-2 diabetes and at least two of the following cardiovascular risk factors:
- •urinary albumin excretion > 30 mg/L or > 30 mg/24 hours,
- •treated or untreated hypertension,
- •treated or untreated lipid abnormality,
- •peripheral arterial disease,
- •history of transient ischemic accident,
- •tobacco consumption
- •familial history of premature cardiovascular disease.
排除标准
- •History of myocardial infarction, coronary artery disease, or stroke,
- •Previous positive stress test or myocardial perfusion imaging,
- •Negative stress test or myocardial perfusion imaging within the last three years
结局指标
主要结局
Death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention, measured after a minimum follow-up of 2 years
次要结局
- Unstable angina requiring hospitalization Coronary events Coronary revascularization