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Completed

NCT Number: NCT00607178

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

influenza vaccine

Biological

Intramuscular injection of one 0.5-mL dose of influenza vaccine

Other names: 2006-2007 vaccination campaign of Influvac (SolvayPharma)

placebo for influenza vaccine

Biological

Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine

Primary outcomes

  1. Cardiovascular death

    Time frame: 6 months

Secondary outcomes

  1. Acute coronary syndrome (MI or unstable angina)

    Time frame: 6 months

  2. Admission for Coronary Artery Disease

    Time frame: 6 months

  3. Angina severity (Seattle Angina Questionnaire [10])

    Time frame: 6 months

  4. Coronary artery stenosis (modified Gensini score [11])

    Time frame: 6 months

  5. Coronary revascularization (artery bypass graft or percutaneous coronary intervention)

    Time frame: 6 months

  6. Influenza infection

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Randomized, Single-Blind, Placebo-Controlled Study of Influenza Vaccine in Preventing Cardiovascular Events in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris

Acronym: IVCAD

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 5, 2008
Registry last updated
Jan 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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