ISRCTN65663256已完成不适用
Multicenter trial of elective revascularization in patients with diabetes mellitus and mild anginal complaints
Academic Medical Centre (AMC) (Netherlands)0 个研究点目标入组 800 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. A history of diabetes mellitus type 2, evidenced by either of the following
- •1.1 Treatment with oral antidiabetic medication
- •1.2 Treatment with insulin after a period of treatment with oral antidiabetic medication
- •1.3 Treatment with insulin, started after the 50th year
- •1.4 A fasting plasma glucose concentration of at least 7.0 mmol/l or a non-fasting glucose concentration of at least 11.0 mmol/l, in two samples taken on separate days
- •2. Stable mild complaints of angina pectoris (Canadian Cardiovascular Society class I or II, on medical treatment)
排除标准
- •1. Younger than 30 years of age
- •2. Previous myocardial infarction and/or acute coronary syndrome in the previous two months
- •3. Unstable angina (any category in Braunwald's classification) in the previous two months
- •4. Previous percutaneous intervention in the previous six months
- •5. Serious complaints of effort angina pectoris (CCS class III or IV)
- •6. Known coronary anatomy unsuited for coronary revascularization
- •7. An ejection fraction of less than 35%, measured by any technique
- •8. Contra-indication for bypass surgery (i.e. co-morbidity)
- •9. History of a hemorrhagic stroke at any time, or stroke or transient ischemic accident (TIA) of any etiology within 30 days of randomization
- •10. History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days of randomization
- •11. Known platelet count of <100,000/mm3
- •12. Severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure over 100 mmHg, after treatment)
- •13. Major surgery within 6 weeks prior to randomization
- •14. Congenital heart disease
- •15. Apparent cardiomyopathy
- •16. Severe valvular heart disease
- •17. Serious bronchial asthma
- •18. Malignancies or other diseases with a limited life expectancy
- •19. Serious kidney failure (plasma creatinin level >250 µmol/l)
- •20. Body-weight >120 kg
- •21. Co-existent condition associated with a limited life expectancy
- •22. Previous participation in this study or any other trial within the previous 30 days
- •23. Circumstances that prevent follow-up (no permanent home or address, transient etc.)
- •24. Pregnant women or women of child bearing potential who do not use adequate contraception
- •25. Familial hypercholesterolemia or an LDL cholesterol concentration over 55 mmol/l (after treatment)
研究者
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