The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Coronary Artery Diseases; Stable Angina; Myocardial Infarction

Treatments: Biological: placebo for influenza vaccine; Biological: influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00607217

SMMC- 13861008B

SBMU- 86-03-105-5433B

Details and patient eligibility

About

This study wishes to understand:

1. whether vaccination against influenza in coronary artery disease (myocardial infarction and stable angina) patients is as effective as it is in healthy subjects;
2. whether vaccination really decreases the episodes of influenza infection in those coronary artery disease patients who receive the vaccine than those who do not.

Full description

Influenza infection may become complicated in patients with chronic conditions, including coronary artery disease (CAD) [1]. Influenza vaccination is now recommended as part of comprehensive secondary prevention in individuals with coronary and other atherosclerotic vascular disease (evidence level: Class I, Level B) [2]. Although there is controversial evidence pro [3,4] and against [5] the efficacy of influenza vaccination in protecting CAD population against cardiovascular events, the efficacy of vaccine in actual reduction in episodes of influenza infection and its fatal complications in CAD patients has not been, to our knowledge, well studied before. Furthermore, we found no report comparing serologic response to the influenza vaccine antigens between CAD patients and healthy controls.

This study aims to identify the efficacy of influenza vaccination in CAD individuals in terms of both serologic response (as compared with healthy individuals) and clinical outcomes (as compared with CAD patients not vaccinated).

Enrollment: 360 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Coronary artery disease (CAD) group (CAD-Exp and CAD-Control):

• Patients with the diagnosis of acute, evolving or recent MI (after recovered the acute phase) as defined by:

  1. Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:

• Ischemic symptoms

• Development of pathologic Qwaves on the ECG

• ECG changes indicative of ischemia (ST segment elevation or depression); OR

• Coronary artery intervention (e.g., coronary angioplasty). 2. Pathologic findings of an acute MI [1]:

• Patients with stable angina pectoris (SA) and documented coronary artery stenosis (angiography).

• Healthy Control group: healthy controls, proportionally matched by gender and age with the patient group (separate control groups for MI and SA patients).

Exclusion criteria

• Any acute disease
• Chronic liver or kidney diseases
• Conditions accompanied by immunosuppression (like organ transplantation, HIV)
• Diagnosed malignancy
• Incubation with influenza vaccine within the past 5 years
• Any psychological disease that interferes with regular follow-up
• Congestive heart failure (Killip class IV)
• Unstable angina; AND
• Contradictions of vaccine incubation (like egg allergy).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

360 participants in 3 patient groups, including a placebo group

CAD-Exp

Experimental group

Description:

Enrolled coronary artery disease patients who are randomly assigned to receive influenza vaccine

Treatment:

Biological: influenza vaccine

Biological: influenza vaccine

CAD-Control

Placebo Comparator group

Description:

Enrolled coronary artery disease patients who are randomly assigned to receive placebo of influenza vaccine

Treatment:

Biological: placebo for influenza vaccine

Healthy-Control

Experimental group

Description:

Enrolled healthy subjects serve as control for CAD-Exp

Treatment:

Biological: influenza vaccine

Biological: influenza vaccine