The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

Last updated: January 20, 2009
Sponsor: Shahid Beheshti University of Medical Sciences
Overall Status: Completed

Phase

2/3

Condition

Blood Clots

Thrombosis

Cardiac Ischemia

Treatment

N/A

Clinical Study ID

NCT00607217
SBMU- 86-03-105-5433B
SMMC- 13861008B
  • Ages > 25
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 acutephase) as defined by:

  1. Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) ofbiochemical 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 ofan 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 withthe patient group (separate control groups for MI and SA patients).

Exclusion

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).

Study Design

Total Participants: 360
Study Start date:
January 01, 2008
Estimated Completion Date:
September 30, 2008

Study 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).

Connect with a study center

  • Shaheed Modarres Medical Center

    Tehran,
    Iran, Islamic Republic of

    Site Not Available

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