Influenza vaccine reduces the cardiovascular events in post-myocardial infarction (MI) patients and in those with stable angina (SA).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
300
Intramuscular injection of one 0.5-mL dose of influenza vaccine
Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine
Shaheed Modarres Medical Center
Tehran, Tehran Province, Iran
Cardiovascular death
Time frame: 6 months
Acute coronary syndrome (MI or unstable angina)
Time frame: 6 months
Admission for Coronary Artery Disease
Time frame: 6 months
Angina severity (Seattle Angina Questionnaire [10])
Time frame: 6 months
Coronary artery stenosis (modified Gensini score [11])
Time frame: 6 months
Coronary revascularization (artery bypass graft or percutaneous coronary intervention)
Time frame: 6 months
Influenza infection
Time frame: 6 months
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