Skip to content

Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction

Phase 4 Study of the Effect of Simvastatin Treatment on Inflammatory Response and Endothelial Function After Myocardial Infarction

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00906451
Enrollment
58
Registered
2009-05-21
Start date
2008-11-30
Completion date
2009-05-31
Last updated
2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Inflammation, Myocardial Infarction

Keywords

myocardial infarction, inflammation, endothelial dysfunction

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.

Interventions

DRUGSimvastatin

Simvastatin

Sponsors

Brasilia Heart Study Group
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Elevation of plasma C reactive proteinFive daysChanges in CRP levels between the first and fifth day after myocardial infarction

Secondary

MeasureTime frame
Brachial Artery Endothelial function30 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026