Health Condition 1: I219- Acute myocardial infarction, unspecified
Conditions
Interventions
Intervention1: Influenza vaccine: Seasonal inactivated quadrivalent Influnenza Vaccine
0.5 ml annually minimum for one year and maximum for three years
Control Intervention1: Placebo: Sterile saline 0
Sponsors
Indian Council of Medical Research, India
Eligibility
Inclusion criteria
Inclusion criteria: - Patients > 45 year old with physician diagnosed MI (ST elevation and non ST elevation) in the previous 12 weeks consenting to participate will be randomized to intervention or control arm
Exclusion criteria
Exclusion criteria: 1) Anaphylactic reaction to a previous dose of influenza vaccine, 2) IgE-mediated hypersensitivity to egg protein manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock; 3) Guillain-Barré syndrome within eight weeks of a previous influenza vaccine; 4) Anaphylactic reaction to neomycin 5) Influenza vaccine in the previous one year; 6) Plan to be vaccinated with flu vaccine in coming year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be a composite of all cause death, non-fatal myocardial infarction, non-fatal stroke and all-cause hospitalizations using standardized criteria from time of randomization during the peak influenza season.Timepoint: Study Duration will be of four year which include 6 months for ethical approvals, sites initiation, training. 6 months of sites close out and data analysis. Patient will be administered study vaccine or placebo annually with minimum follow up of one year and maximum follow up of 2.5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome will be the composite outcome of all cause death, non-fatal myocardial infarction, non-fatal stroke and all cause hospitalizations during the entire period of the study; Individual components of the composite outcome- all-cause death; cardiovascular death; non-fatal myocardial infarction; non-fatal stroke; all-cause hospitalisation; hospitalisation for heart failure; and pneumonia will be the other secondary outcomesTimepoint: Study Duration will be of four year which include 6 months for ethical approvals, sites initiation, training. 6 months of sites close out and data analysis. Patient will be administered study vaccine or placebo annually with minimum follow up of one year and maximum follow up of 2.5 years. | — |
Countries
India
Contacts
Public ContactDr Ambuj Roy
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed