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

Study Description

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 Design

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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

MedlinePlus related topics: Angina Coronary Artery Disease Flu Flu Shot Heart Attack

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Cardiovascular death [ Time Frame: 6 months ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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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).

Contacts and Locations

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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

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Iran, Islamic Republic of
Shaheed Modarres Medical Center
Tehran, Iran, Islamic Republic of, 19814

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

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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)

More Information

Publications:

Gurfinkel E, Lernoud V. The role of infection and immunity in atherosclerosis. Expert Rev Cardiovasc Ther. 2006 Jan;4(1):131-7. Review.

Spodick DH, Flessas AP, Johnson MM. Association of acute respiratory symptoms with onset of acute myocardial infarction: prospective investigation of 150 consecutive patients and matched control patients. Am J Cardiol. 1984 Feb 1;53(4):481-2.

Bainton D, Jones GR, Hole D. Influenza and ischaemic heart disease--a possible trigger for acute myocardial infarction? Int J Epidemiol. 1978 Sep;7(3):231-9.

Gurevich VS. Influenza, autoimmunity and atherogenesis. Autoimmun Rev. 2005 Feb;4(2):101-5. Epub 2004 Nov 20. Review.

Naghavi M, Barlas Z, Siadaty S, Naguib S, Madjid M, Casscells W. Association of influenza vaccination and reduced risk of recurrent myocardial infarction. Circulation. 2000 Dec 19;102(25):3039-45.

Gurfinkel EP, de la Fuente RL, Mendiz O, Mautner B. Influenza vaccine pilot study in acute coronary syndromes and planned percutaneous coronary interventions: the FLU Vaccination Acute Coronary Syndromes (FLUVACS) Study. Circulation. 2002 May 7;105(18):2143-7.

León de la Fuente R, Gurfinkel EP, Toledo D, Mautner B; Grupo de Estudio FLUVACS. [Flu vaccination in patients with acute coronary syndromes: treatment benefit in prespecified subgroups]. Rev Esp Cardiol. 2003 Oct;56(10):949-54. Spanish.

Jackson LA, Yu O, Heckbert SR, Psaty BM, Malais D, Barlow WE, Thompson WW; Vaccine Safety Datalink Study Group. Influenza vaccination is not associated with a reduction in the risk of recurrent coronary events. Am J Epidemiol. 2002 Oct 1;156(7):634-40.

Simonsen L, Taylor RJ, Viboud C, Miller MA, Jackson LA. Mortality benefits of influenza vaccination in elderly people: an ongoing controversy. Lancet Infect Dis. 2007 Oct;7(10):658-66. Review.

Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Prodzinski J, McDonell M, Fihn SD. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol. 1995 Feb;25(2):333-41.

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

Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol. 2000 Sep;36(3):959-69. Erratum in: J Am Coll Cardiol 2001 Mar 1;37(3):973.

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Responsible Party:	Maryam Keshtkar-Jahromi, Infectious Diseases and Tropical Medicine Research Center, SBMU, Tehran, Iran
ClinicalTrials.gov Identifier:	NCT00607178
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:

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Influenza, Human Coronary Artery Disease Myocardial Ischemia Coronary Disease Myocardial Infarction Angina, Stable Infarction 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 Vaccines Immunologic Factors Physiological Effects of Drugs

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