Multicenter trial of elective revascularization in patients with diabetes mellitus and mild anginal complaints

Completed

• Conditions: Diabetes Mellitus type II (DM type II), Coronary artery disease; Nutritional, Metabolic, Endocrine; Non-insulin dependent diabetes

• Registration Number: ISRCTN65663256
• Lead Sponsor: Academic Medical Centre (AMC) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

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)

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
One or more of the following complications within the duration of follow-up:<br>1. All-cause mortality<br>2. Non-fatal myocardial infarction<br>3. Hospital admission for acute coronary syndrome

Secondary Outcome Measures

Name	Time	Method
Each of the above components of the composite endpoint:<br>1. Cardiac mortality<br>2. Newly developed diabetic morbidity (diabetic retinopathy, diabetic nephropathy, and changes in blood glucose regulation) documented in routine clinical practice<br>3. Functional status at one and two years<br>4. Quality of life