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Trial record 21 of 7091 for:    vaccination

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

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

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

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : January 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


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 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




Primary Outcome Measures :
  1. Cardiovascular death [ Time Frame: 6 months ]

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


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607178


Locations
Iran, Islamic Republic of
Shaheed Modarres Medical Center
Tehran, Iran, Islamic Republic of, 19814
Sponsors and Collaborators
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: 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)

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
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: September 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:
Influenza
Vaccine

Additional relevant MeSH terms:
Vaccines
Influenza, Human
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Angina, Stable
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Immunologic Factors
Physiological Effects of Drugs