Stable and mild complaints of coronary artery disease in patients with diabetes mellitus type 2.
Conditions
Interventions
Patients that qualify for admission in the randomized trial are randomly assigned to one of the following treatment strategies:
1. Invasive treatment
2. Continued medical treatment.
Invasive treatment:
Patients undergo coronary angiography as soon as possible after randomization. Angiography can be performed at either the referring center or the
Sponsors
* The Netherlands Heart Foundation (NHS)
* The Netherlands Organisation for Health Research and Development (ZonMw)
Eligibility
Inclusion criteria
Inclusion criteria: 1. A history of diabetes mellitus type 2, evidenced by either of the following: a. Treatment with oral antidiabetic medication; b. Treatment with insulin after a period of treatment with oral antidiabetic medication; c. Treatment with insulin, started after the 50th year; d. 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
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 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 5.5 mmol/l (after treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One or more of the following complications within the duration of follow-up: a. All-cause mortality; b. Non-fatal myocardial infarction; c. Hospital admission for acute coronary syndrome. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Each of the above components of the composite endpoint; 2. Cardiac mortality; 3. Newly developed diabetic morbidity (diabetic retinopathy, diabetic nephropathy, and changes in blood glucose regulation) documented in routine clinical practice; 4. Functional status at one and two years; 5. Quality of life. | — |
Contacts
Public ContactJ.J. Wiersma
Academic Medical Center (AMC), Department of Cardiology, B2-124, P.O. Box 22660
Outcome results
None listed