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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00607178
First received: January 10, 2008
Last updated: January 20, 2009
Last verified: September 2008
  Purpose

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


Condition Intervention Phase
Coronary Artery Diseases
Myocardial Infarction
Stable Angina
Biological: influenza vaccine
Biological: placebo for influenza vaccine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • Cardiovascular death [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute coronary syndrome (MI or unstable angina) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Admission for Coronary Artery Disease [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Angina severity (Seattle Angina Questionnaire [10]) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Coronary artery stenosis (modified Gensini score [11]) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Coronary revascularization (artery bypass graft or percutaneous coronary intervention) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Influenza infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607178

Locations
Iran, Islamic Republic of
Shaheed Modarres Medical Center
Tehran, Iran, Islamic Republic of, 19814
Sponsors and Collaborators
Shahid Beheshti Medical University
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: Ali Eskandari, MD Shahid Beheshti Medical University
Principal Investigator: Mohammad Rahnavardi, MD Shahid Beheshti Medical University
Principal Investigator: Sharareh Gholamin, MD Shaheed Beheshti University (MC)
Principal Investigator: Seyed Mostafa Razavi, MD Shaheed Beheshti University (MC)
  More Information

Publications:
Gensini GG. Coronary Angiography. Mount Kisco, NY: Futura Publishing Co; 1975.

Responsible Party: Maryam Keshtkar-Jahromi, Infectious Diseases and Tropical Medicine Research Center, SBMU, Tehran, Iran
ClinicalTrials.gov Identifier: NCT00607178     History of Changes
Other Study ID Numbers: SBMU- 86-03-105-5433A, SMMC- 13861008A
Study First Received: January 10, 2008
Last Updated: January 20, 2009
Health Authority: Iran: Ministry of Health

Keywords provided by Shahid Beheshti Medical University:
Influenza
Vaccine

Additional relevant MeSH terms:
Angina, Stable
Coronary Artery Disease
Coronary Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Heart Diseases
Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014