Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906451
• Other study ID #: Simvastatin Post-MI
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2009
• Last updated: June 21, 2011
• Start date: November 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Brasilia Heart Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Infarction
• Inflammation
• Myocardial Infarction

Intervention

Drug:
• Simvastatin
Simvastatin

Locations

Country	Name	City	State
Brazil	Hospital de Base do Distrito Federal	Brasilia	DF

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia Heart Study Group

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Sposito AC, Santos SN, de Faria EC, Abdalla DS, da Silva LP, Soares AA, Japiassú 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. A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elevation of plasma C reactive protein	Changes in CRP levels between the first and fifth day after myocardial infarction	Five days	No
Secondary	Brachial Artery Endothelial function		30 days	No