Clinical trial NCT00906451: Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction
Official title: Phase 4 Study of the Effect of Simvastatin Treatment on Inflammatory Response and Endothelial Function After Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Inflammation
Endothelial Dysfunction
Keywords: myocardial infarction
inflammation
endothelial dysfunction
Lead sponsor: Brasilia Heart Study Group
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 58
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: During myocardial infarction, inflammatory response may negatively influence ventricle wall remodeling as well as endothelium-dependent vasomotor function in the coronary and systemic arterial systems. Statins have been consistently proved to attenuate inflammation and improve endothelial function. In this study, we tested the effect of different doses of statin on inflammatory response and endothelium-dependent vasodilation.

Detailed description: 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. The intensity of this inflammatory upregulation is strongly related to the incidence of recurrent coronary events. High dose potent statins can rapidly reduce plasma levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during ACS. By inference, it is plausible to hypothesize that these effects during the acute phase of myocardial infarction may influence the post-discharge endothelial dysfunction. So far, data is unavailable to verify this assumption or to define the potency required for such statin anti-inflammatory effect in myocardial infarction patients. The present study aim to investigate the role of statin dose on the time-course of the inflammatory response during the acute phase of myocardial infarction and its late effect on endothelium-dependent arterial dilation.

Eligibility criteria: Inclusion Criteria:

* Less than 24 hours after the onset of MI 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 at least 6 months prior the myocardial infarction

Primary outcomes:
measure: Elevation of plasma C reactive protein
timeFrame: Five days
Secondary outcomes:
measure: Brachial Artery Endothelial function
timeFrame: 30 days
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital de Base do Distrito Federal
state: DF
Study officials:
affiliation: University of Brasilia Medical School
name: Andrei C Sposito, MD, PhD
role: STUDY_CHAIR
References:
citation: Sposito AC, Santos SN, de Faria EC, Abdalla DS, da Silva LP, Soares AA, Japiassu AV, Quinaglia e Silva JC, Ramires JA, Coelho OR. Timing and dose of statin therapy define its impact on inflammatory and endothelial responses during myocardial infarction. Arterioscler Thromb Vasc Biol. 2011 May;31(5):1240-6. doi: 10.1161/ATVBAHA.110.218685. Epub 2011 Mar 3.