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Completed

NCT Number: NCT00607217

The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

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.

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Key information

Conditions

Coronary Artery Diseases Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Infarction Infections Influenza, Human Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Orthomyxoviridae Infections Pain Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Stable Angina Vascular Diseases Virus Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shaheed Modarres Medical Center

Tehran, Tehran Province, Iran

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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:
  • 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).

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. Influenza infection

    Time frame: 6 months

  2. Serologic response (≥4-fold HI titer rise) to each of the 3 antigens of the trivalent vaccine of the 2006-07 campaign [Solomon Islands/3/2006(H1N1), Wisconsin/67/2005 (H3N2), and Malaysia/2506/2004 - like strains]

    Time frame: 1 month

Secondary outcomes

  1. Magnitude of change in the antibody titer against each of the three influenza vaccine antigens

    Time frame: 1 month

  2. Protective antibody (≥1:40) titer after vaccination

    Time frame: 1 month

  3. Influenza-related death

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Controlled Trial of Serologic and Clinical Efficacy of Influenza Vaccine in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris

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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