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

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

NCT00607178

SMMC- 13861008A

SBMU- 86-03-105-5433A

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 [12]

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

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

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300 participants in 2 patient groups, including a placebo group

Influenza vaccine

Experimental group

Description:

Enrolled patients who are randomly assigned to receive influenza vaccine

Treatment:

Biological: influenza vaccine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: placebo for influenza vaccine