Screening Asymptomatic Patients With Diabetes for Unknown Coronary Artery Disease: an Open-label Randomized Study Comparing Exercise Testing Strategy With Management Based on Pharmacological/Behavioral Treatment of Traditional Risk Factors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Death and myocardial infarction
研究概览
简要总结
In the present study a cohort of diabetic patients without any symptoms and without known coronary artery disease (CAD) will be screened at the investigators' diabetes outpatients services. Those with intermediate or high risk will be asked to participate and enrolled. They will be seen and followed by the cardiologists in order to provide the best adherence to medical therapy. By mean of a randomization process, a group of patients will undergo an exercise electrocardiography (ECG) testing while the other group will continue to be regularly seen at the investigators' cardiology service. Those patients with a positive exercise ECG test will be study by coronary angiography and treated according to the severity of coronary lesions by percutaneous stenting or surgery. Both groups of patients will be seen every six-eight months for the next three years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 69 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type two Diabetes Mellitus
- •Cardiovascular risk equal or higher than 10% according to Italian risk score (www.cuore.iss.it)
排除标准
- •Known coronary artery disease
- •Symptomatic heart failure
- •Objective inability to perform treadmill exercise
- •Known or active malignancy, advanced renal failure (clearance < 25 ml/mi/1.73m2), liver cirrhosis (child Pugh III); stroke within the past 30 days
- •Presence of left bundle branch block or ST depression at rest greater than 0.9 mm
结局指标
主要结局
Death and myocardial infarction
时间窗: three years
次要结局
- Symptomatic heart failure(three years)
研究者
TURRINI FABRIZIO
Turrini fabrizio MD
Azienda Unita' Sanitaria Locale Di Modena
