Randomised trial to evaluate the clinical value of intensive glucose monitoring and regulation in Acute Coronary Syndromes

Completed

Conditions: Myocardial Infarction in diabetes
10011082

Registration Number: NL-OMON32341

Lead Sponsor: Medisch Centrum Alkmaar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

Myocardial infarction and hyperglycemia

Exclusion Criteria

1. A history of insulin dependent diabetes mellitus (note that patients with non-insulin dependent diabetes mellitus can be included).
2. Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease (e.g. arrhythmia, severe anemia, hypoxia, thyrotoxicosis, cocaine, severe valvular disease, hypotension).
3. Known severely-impaired left ventricular function (ejection fraction <30%) or end-stage congestive heart failure NYHA-class III or IV at presentation (in order to avoid lost-to-follow-up due to non-acute coronary syndrome events).
4. Severe chronic kidney disease with measured or calculated glomerular filtration rate (Cockgroft-Gault or MDRD4 (Modification of Diet in Renal Disease) formula) of <30 ml/min/1.73m2, or renal dialysis40.
5. Co-existent condition associated with a life-expectancy <1 year.
6. Patient is expected to be transferred to another hospital within 48 hours.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Extend of myocardial damage expressed by Troponin T level at 72 hours.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Left Ventricle Ejection Fraction (LVEF) and infarct size at 6 weeks<br /><br>Extend of myocardial damage as expressed by area under CKMB curve.<br /><br>ST segment resolution after 6 hours<br /><br>Serum NTpro BNP values after 0 & 72 hours and 6 weeks<br /><br>Mortality and non fatal re-infarction<br /><br>HbA1C and fasting glucose values at 6 weeks.<br /><br>Biomarkers of (vascular) inflammation, hypercoagulability or neurohumoral<br /><br>activation at admission, 24, 48 and 72 hours and 6 weeks after randomization</p><br>