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
- 1
- 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
研究组 & 干预措施
Intervention
Patients are referred to a cardiologist for a systematic detection of silent ischemia by a bicycle exercise test performed according to the French Society of Cardiology protocol after washout of cardiovascular medications likely to interfere with the test. Dipyridamole Single Photon Emission Computed Tomography (SPECT) is used in patients unable to perform the exercise test, with a sub-maximal negative exercise test result or with electrocardiographic abnormalities impairing the interpretation of the exercise test. Subsequent investigations (such as coronary angiography) and treatments (such as revascularization procedures) are left at the cardiologist's decision.
干预措施: a bicycle exercise test (Other)
Control
Patients are treated according current guidelines but are not referred to a cardiologist
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