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

Myocardial Infarction Clinical Trial

— IVCAD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607178
• Other study ID #: SBMU- 86-03-105-5433A
• Secondary ID: SMMC- 13861008A
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 10, 2008
• Last updated: January 20, 2009
• Start date: January 2008
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Artery Disease
• Coronary Artery Diseases
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Stable Angina

Intervention

Biological:
• influenza vaccine
Intramuscular injection of one 0.5-mL dose of influenza vaccine
• placebo for influenza vaccine
Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shaheed Modarres Medical Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (12)

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. — View Citation

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. — View Citation

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

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular death		6 months	No
Secondary	Acute coronary syndrome (MI or unstable angina)		6 months	Yes
Secondary	Admission for Coronary Artery Disease		6 months	Yes
Secondary	Angina severity (Seattle Angina Questionnaire [10])		6 months	No
Secondary	Coronary artery stenosis (modified Gensini score [11])		6 months	No
Secondary	Coronary revascularization (artery bypass graft or percutaneous coronary intervention)		6 months	No
Secondary	Influenza infection		6 months	No