跳至主要内容
临床试验/NCT00547872
NCT00547872已完成3 期

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

TURRINI FABRIZIO2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2007年9月最近更新:
适应症

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

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

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

TURRINI FABRIZIO

Turrini fabrizio MD

Azienda Unita' Sanitaria Locale Di Modena

研究点 (2)

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