Patients with coronary artery disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients who request influenza vaccination 2) Patients with coronary artery disease (1) Patients with >=50% diameter stenosis diagnosed by coronary angiography (2) History of myocardial infarction (3) History of coronary revascularization
Exclusion criteria
Exclusion criteria: 1) History of pneumococcal infection 2) Patients treated with pneumococcal vaccination previously 3) Patients treated with another vaccination within 3 months 4) Patients with allergy against vaccine component, egg, chicken, and chicken-derived ingredients 5) Patients with fever 6) Patients with acute and severe diseases 7) Patients with liver disorder (AST and/or ALT: 2.5 times or larger than upper normal limits) 8) Patients with renal disorder (creatinine level >= 2.0 mg/dL) 9) History of myocardial infarction within 6 months 10) History of coronary revascularization within 3 months 11) Patients with congestive heart failure (NYHA Class III or IV) 12) Patients with poor control diabetes (HbA1c >= 10%) 13) Patients with poor control hypertension (SBP >= 200mmHg or DBP >= 110mmHg) 14) Patients who judged as ineligible by clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy for cardiovascular biomarkers | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevalence of influenza and pneumococcal infection, changes of complete blood cell count, liver function, renal function, glucose tolerance, and lipid profiles | — |
Countries
Japan
Contacts
Juntendo University School of Medicine Department of Cardiology