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

January 20, 2009 updated by: Shahid Beheshti University of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Influenza vaccine
Enrolled patients who are randomly assigned to receive influenza vaccine
Biological: influenza vaccine
Intramuscular injection of one 0.5-mL dose of influenza vaccine
Other Names:
  • 2006-2007 vaccination campaign of Influvac (SolvayPharma)
Placebo Comparator: Placebo
Enrolled patients who are randomly assigned to receive placebo of influenza vaccine
Biological: placebo for influenza vaccine
Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular death
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Influenza infection
Time Frame: 6 months
6 months
Acute coronary syndrome (MI or unstable angina)
Time Frame: 6 months
6 months
Admission for Coronary Artery Disease
Time Frame: 6 months
6 months
Angina severity (Seattle Angina Questionnaire [10])
Time Frame: 6 months
6 months
Coronary artery stenosis (modified Gensini score [11])
Time Frame: 6 months
6 months
Coronary revascularization (artery bypass graft or percutaneous coronary intervention)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • 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: Sharareh Gholamin, MD, Shaheed Beheshti University (MC)
  • Principal Investigator: Seyed Mostafa Razavi, MD, Shaheed Beheshti University (MC)
  • Principal Investigator: Ali Eskandari, MD, Shahid Beheshti University of Medical Sciences
  • Principal Investigator: Mohammad Rahnavardi, MD, Shahid Beheshti University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 5, 2008

Study Record Updates

Last Update Posted (Estimate)

January 22, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBMU- 86-03-105-5433A
  • SMMC- 13861008A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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