Multicenter trial of elective revascularization in patients with diabetes mellitus and mild anginal complaints.
Suspended
- Conditions
- Stable and mild complaints of coronary artery disease in patients with diabetes mellitus type 2.
- Registration Number
- NL-OMON20816
- Lead Sponsor
- * The Netherlands Heart Foundation (NHS)* The Netherlands Organisation for Health Research and Development (ZonMw)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 800
Inclusion Criteria
1. A history of diabetes mellitus type 2, evidenced by either of the following:
Exclusion Criteria
1. Younger than 30 years of age;
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 /><br>a. All-cause mortality;<br /><br>b. Non-fatal myocardial infarction;<br /><br>c. Hospital admission for acute coronary syndrome.
- Secondary Outcome Measures
Name Time Method 1. Each of the above components of the composite endpoint;<br /><br>2. Cardiac mortality;<br /><br>3. Newly developed diabetic morbidity (diabetic retinopathy, diabetic nephropathy, and changes in blood glucose regulation) documented in routine clinical practice;<br /><br>4. Functional status at one and two years;<br /><br>5. Quality of life.