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

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ClinicalTrials.gov Identifier: NCT00607178
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : January 22, 2009
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE January 10, 2008
First Posted Date  ICMJE February 5, 2008
Last Update Posted Date January 22, 2009
Study Start Date  ICMJE January 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2008)
Cardiovascular death [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2008)
  • Acute coronary syndrome (MI or unstable angina) [ Time Frame: 6 months ]
  • Admission for Coronary Artery Disease [ Time Frame: 6 months ]
  • Angina severity (Seattle Angina Questionnaire [10]) [ Time Frame: 6 months ]
  • Coronary artery stenosis (modified Gensini score [11]) [ Time Frame: 6 months ]
  • Coronary revascularization (artery bypass graft or percutaneous coronary intervention) [ Time Frame: 6 months ]
  • Influenza infection [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Influenza Vaccine in Reducing Cardiovascular Events in Patients With Coronary Artery Diseases
Official Title  ICMJE 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
Brief Summary Influenza vaccine reduces the cardiovascular events in post-myocardial infarction (MI) patients and in those with stable angina (SA).
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Coronary Artery Diseases
  • Myocardial Infarction
  • Stable Angina
Intervention  ICMJE
  • Biological: influenza vaccine
    Intramuscular injection of one 0.5-mL dose of influenza vaccine
    Other Name: 2006-2007 vaccination campaign of Influvac (SolvayPharma)
  • Biological: placebo for influenza vaccine
    Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine
Study Arms  ICMJE
  • Experimental: Influenza vaccine
    Enrolled patients who are randomly assigned to receive influenza vaccine
    Intervention: Biological: influenza vaccine
  • Placebo Comparator: Placebo
    Enrolled patients who are randomly assigned to receive placebo of influenza vaccine
    Intervention: Biological: placebo for influenza vaccine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 4, 2008)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00607178
Other Study ID Numbers  ICMJE SBMU- 86-03-105-5433A
SMMC- 13861008A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maryam Keshtkar-Jahromi, Infectious Diseases and Tropical Medicine Research Center, SBMU, Tehran, Iran
Study Sponsor  ICMJE Shahid Beheshti University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Maryam Keshtkar-Jahromi, M.D.; M.P.H. Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran
Principal Investigator: Hossein Vakili, M.D. Cardiovascular Research Center, Shaheed Beheshti Medical University, Tehran, Iran
Principal Investigator: Ali Eskandari, MD Shahid Beheshti University of Medical Sciences
Principal Investigator: Mohammad Rahnavardi, MD Shahid Beheshti University of Medical Sciences
Principal Investigator: Sharareh Gholamin, MD Shaheed Beheshti University (MC)
Principal Investigator: Seyed Mostafa Razavi, MD Shaheed Beheshti University (MC)
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP