Myocardial Infarction
Conditions
Keywords
myocardial infarction, systemic inflammatory activity, endothelial function
Brief summary
During acute coronary syndromes (ACS), the generation of inflammatory mediators negatively influences arterial wall remodeling and the endothelium-dependent vasomotor function in the coronary and systemic arterial systems. In fact, the intensity of the inflammatory upregulation is strongly related to the incidence of recurrent coronary events. The investigators previously demonstrated that high dose potent statins can rapidly reduce plasma levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during ACS. In addition, such statin treatment attenuates the post-discharge endothelial dysfunction of these patients. By inference, it is plausible to hypothesize that these beneficial effects during ACS may be intensified by an additive lowering of plasma cholesterol through the treatment with ezetimibe. So far, data is unavailable to verify this assumption. In parallel, data from animal models have suggested that both statins and ezetimibe may reduce insulin sensitivity by their effect on cholesterol content and, by this way, on insulin signaling in liver cells. In this context, the present study aims to investigate the role of the addition of ezetimibe upon statin treatment on stress-induced insulin resistance and on the time-course of the inflammatory response during the acute phase of myocardial infarction and its late effect on endothelium-dependent arterial dilation.
Interventions
DRUGSimvastatin
Simvastatin 40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation
DRUGEzetimibe-Simvastatin
Ezetimibe-Simvastatin 10-40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation
Sponsors
Brasilia Heart Study Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* less than 24 hours after the onset of myocardial infarction symptoms * ST-segment elevation of a least 1 mm (frontal plane) or 2 mm (horizontal plane) in two contiguous leads * myocardial necrosis, as evidenced by increased CK-MB and troponin levels
Exclusion criteria
* use of statins for the last 6 months before myocardial infarction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C- reactive Protein (CRP) elevation during the first 7 days after myocardial infarction | 5th day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function 30 days after myocardial infarction | 30th day | — |
| Stress Insulin Resistance | 5th day | Evaluation of the change in plasma glucose, insulin and C-peptide from admission to the fifth day after myocardial infarction |
Countries
Brazil
Outcome results
None listed