NCT00607178

The Efficacy of Influenza Vaccine in Reducing Cardiovascular Events in Patients With Coronary Artery Diseases

Randomized, Single-Blind, Placebo-Controlled Study of Influenza Vaccine in Preventing Cardiovascular Events in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

Influenza vaccine reduces the cardiovascular events in post-myocardial infarction (MI) patients and in those with stable angina (SA).

Detailed description

A connection between infectious processes and atherosclerosis is repeatedly reported \[1\]. Acute respiratory infection was found to be associated with myocardial infarction (MI) \[2,3\] and a number of epidemiological studies found that mortality attributable to cardiovascular diseases is increased during influenza epidemics \[4\]. Naghavi et al \[5\] in a case-control study of patients with coronary artery disease (CAD) found that vaccination against influenza was negatively associated with the development of new MI during the same influenza season. While some clinical trials found influenza vaccine effective in secondary prevention of cardiovascular adverse events \[6,7\], a large trial \[8\] failed to approve such an efficacy. Furthermore, a recent review of published trials on the subject concluded that frailty selection bias and use of non-specific endpoints such as all cause mortality have led cohort studies to greatly exaggerate vaccine benefits and that the remaining evidence base is currently insufficient to indicate the magnitude of the mortality benefit of the vaccination program \[9\]. This study aims to assess the efficacy of vaccine in secondary prevention of cardiovascular events in MI and stable angina (SA) patients using specific endpoints including reliable quantitative tools.

Conditions

• Coronary Artery Diseases
• Myocardial Infarction
• Stable Angina

Interventions

Type	Name	Description
BIOLOGICAL	influenza vaccine	Intramuscular injection of one 0.5-mL dose of influenza vaccine
BIOLOGICAL	placebo for influenza vaccine	Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-02-05
• Last updated: 2009-01-22

Locations

1 site across 1 country: Iran