Strict glycaemic control in ST-elevation myocardial infarction patients at the coronary care unit using the Paradigm® Real-Time system
Completed
- Conditions
- ST-elevated myocardial infarction, hyperglycaemiaCirculatory SystemAcute myocardial infarction
- Registration Number
- ISRCTN55085730
- Lead Sponsor
- Academic Medical Centre (AMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1. Signed informed consent
2. Admitted to the Critical Care Unit (CCU) after primary percutanerous transluminal coronary angioplasty (PTCA) for acute STEMI
3. Admission glucose concentration greater than or equal to 7.7 mmol/l, either known or not known with previous diabetes mellitus
4. Aged 30 - 80 years, inclusive, either sex
Exclusion Criteria
1. Known type 1 diabetes mellitus
2. Abdominal abnormalities that might hinder either glucose measurement by the sensor or the continuous subcutaneous insulin infusion
3. Any condition that the local investigator feels would interfere with trial participation or the evaluation of results
4. Simultaneous participation in other studies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Areas under the curve (AUCs) and percentage of time spent greater than or equal to 7.7 mmol/l and less than or equal to 3.9 mmol/l per patient as assessed by the Paradigm® Real-Time system in the treatment group compared to the control group.<br><br>All endpoints (both primary and secondary) will be measured at 48 and 72 hours after admission.
- Secondary Outcome Measures
Name Time Method 1. Mean absolute difference between reference blood glucose and glucose values measured by the Paradigm® Real-Time system<br>2. Bland Altman analysis of the reference blood glucose and glucose values measured by the Paradigm® Real-Time system<br>3. ST resolution, difference between intervention and control group<br>4. Changes in cardiological parameters, differences between intervention and control group<br><br>All endpoints (both primary and secondary) will be measured at 48 and 72 hours after admission.