The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases - Full Text View

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00607217

Purpose

This study wishes to understand:

whether vaccination against influenza in coronary artery disease (myocardial infarction and stable angina) patients is as effective as it is in healthy subjects;
whether vaccination really decreases the episodes of influenza infection in those coronary artery disease patients who receive the vaccine than those who do not.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	Controlled Trial of Serologic and Clinical Efficacy of Influenza Vaccine in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease Flu Heart Attack

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

Influenza infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Serologic response (≥4-fold HI titer rise) to each of the 3 antigens of the trivalent vaccine of the 2006-07 campaign [Solomon Islands/3/2006(H1N1), Wisconsin/67/2005 (H3N2), and Malaysia/2506/2004 - like strains] [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Magnitude of change in the antibody titer against each of the three influenza vaccine antigens [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Protective antibody (≥1:40) titer after vaccination [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Influenza-related death [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
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: CAD-Exp Enrolled coronary artery disease 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: CAD-Control Enrolled coronary artery disease 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
Experimental: Healthy-Control Enrolled healthy subjects serve as control for CAD-Exp	Biological: influenza vaccine Intramuscular injection of one 0.5-mL dose of influenza vaccine Other Name: 2006-2007 vaccination campaign of Influvac (SolvayPharma)

Detailed Description:

Influenza infection may become complicated in patients with chronic conditions, including coronary artery disease (CAD) [1]. Influenza vaccination is now recommended as part of comprehensive secondary prevention in individuals with coronary and other atherosclerotic vascular disease (evidence level: Class I, Level B) [2]. Although there is controversial evidence pro [3,4] and against [5] the efficacy of influenza vaccination in protecting CAD population against cardiovascular events, the efficacy of vaccine in actual reduction in episodes of influenza infection and its fatal complications in CAD patients has not been, to our knowledge, well studied before. Furthermore, we found no report comparing serologic response to the influenza vaccine antigens between CAD patients and healthy controls.

This study aims to identify the efficacy of influenza vaccination in CAD individuals in terms of both serologic response (as compared with healthy individuals) and clinical outcomes (as compared with CAD patients not vaccinated).

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Coronary artery disease (CAD) group (CAD-Exp and CAD-Control):
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 [1]:
Patients with stable angina pectoris (SA) and documented coronary artery stenosis (angiography).
Healthy Control group: healthy controls, proportionally matched by gender and age with the patient group (separate control groups for MI and SA patients).

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607217

Locations

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

Sponsors and Collaborators

Shaheed 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:	Mohammad Rahnavardi, M.D.	Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran
Principal Investigator:	Ali Eskandari, MD	Shaheed Beheshti University (MC)
Principal Investigator:	Sharareh Gholamin, MD	Shaheed Beheshti University (MC)
Principal Investigator:	Seyed Mostafa Razavi, MD	Shaheed Beheshti University (MC)

More Information

Publications:

Thompson WW, Shay DK, Weintraub E, Brammer L, Bridges CB, Cox NJ, Fukuda K. Influenza-associated hospitalizations in the United States. JAMA. 2004 Sep 15;292(11):1333-40.

Smith SC Jr, Allen J, Blair SN, Bonow RO, Brass LM, Fonarow GC, Grundy SM, Hiratzka L, Jones D, Krumholz HM, Mosca L, Pasternak RC, Pearson T, Pfeffer MA, Taubert KA; AHA/ACC; National Heart, Lung, and Blood Institute. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update: endorsed by the National Heart, Lung, and Blood Institute. Circulation. 2006 May 16;113(19):2363-72. No abstract available. Erratum in: Circulation. 2006 Jun 6;113(22):e847.

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.

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.

Responsible Party:	Maryam Keshtkar-Jahromi, Infectious Diseases and Tropical Medicine Research Center, SBMU, Tehran, Iran
ClinicalTrials.gov Identifier:	NCT00607217 History of Changes
Other Study ID Numbers:	SBMU- 86-03-105-5433B, SMMC- 13861008B
Study First Received:	January 10, 2008
Last Updated:	January 20, 2009
Health Authority:	Iran: Ministry of Health

Keywords provided by Shaheed Beheshti Medical University:

Coronary artery diseases
Myocardial infarction
Stable angina
Influenza
Vaccine

Additional relevant MeSH terms:

Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Influenza, Human
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain

Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 13, 2012