Evaluate the outcomes of a relatively brief but intensive IV insulin therapy compared to conventional therapy in patients admitted for ACS and observe different biomarker washout patterns these treatment groups.Furthermore we wish to determine…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Extend of myocardial damage expressed by Troponin T level at 72 hours.
Secondary outcome
Left Ventricle Ejection Fraction (LVEF) and infarct size at 6 weeks
Extend of myocardial damage as expressed by area under CKMB curve.
ST segment resolution after 6 hours
Serum NTpro BNP values after 0 & 72 hours and 6 weeks
Mortality and non fatal re-infarction
HbA1C and fasting glucose values at 6 weeks.
Biomarkers of (vascular) inflammation, hypercoagulability or neurohumoral
activation at admission, 24, 48 and 72 hours and 6 weeks after randomization
Background summary
Approximately 40% of patients admitted with ACS have admission hyperglycemia.
It has been shown that this has a deleterious prognostic effect, but it has not
prospectively been shown that lowering these values leads to better outcomes.
Nor has a it been shown what stratgey will work adequately.
We believe that lowering even slightly raised glycemic values will help to
limit myocardial infarct size.
The lack of an univocal treatment strategy was very recently addressed in an
AHA scientific statement by Deedwania et al calling for further research in
this manner.
See:
Deedwania et al; Hyperglycemia and Acute Coronary Syndrome A Scientific
Statement From the American Heart Association Diabetes Committee of the Council
on Nutrition, Physical Activity,and Metabolism. Circulation. 2008 Mar
25;117(12):1610-9. Epub 2008 Feb 25.)
Study objective
Evaluate the outcomes of a relatively brief but intensive IV insulin therapy
compared to conventional therapy in patients admitted for ACS and observe
different biomarker washout patterns these treatment groups.
Furthermore we wish to determine whether certain patient groups may benefit
more from intensive treatment.
Study design
Single centre, prospective, randomised clinical trail
Intervention
Intensive (48 hours IV insulin) vs. conventional (current expectative
treatment)
Study burden and risks
All study participants will additionaly (to standard care) undergo an oral
glucose tolerance test, 6 extra bloodsamples and MIBI spect. As described in
question E6 is the main additional risk a minor amount of radiation (ca 6 a 7
mSv)
OGTT and bloodsamples carry no noteworthy risks
The intensive treatment group also receives 48hrs IV insulin. We propose that
the risk for hypoglycemia is low compared to our current protocol since
glucosevalues will be intensively monitored.
wilhelminalaan 12
1815 JD Alkmaar
NL
wilhelminalaan 12
1815 JD Alkmaar
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-001510-24-NL |
| CCMO | NL22223.094.08 |