The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

Myocardial Infarction Clinical Trial

Official title:

Controlled Trial of Serologic and Clinical Efficacy of Influenza Vaccine in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607217
• Other study ID #: SBMU- 86-03-105-5433B
• Secondary ID: SMMC- 13861008B
• 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

This study wishes to understand:

1. whether vaccination against influenza in coronary artery disease (myocardial infarction and stable angina) patients is as effective as it is in healthy subjects;

2. whether vaccination really decreases the episodes of influenza infection in those coronary artery disease patients who receive the vaccine than those who do not.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: 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
• influenza vaccine
Intramuscular injection of one 0.5-mL dose of 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 (6)

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

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

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. Erratum in: Circulation. 2006 Jun 6;113(22):e847. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influenza infection		6 months	No
Primary	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]		1 month	No
Secondary	Magnitude of change in the antibody titer against each of the three influenza vaccine antigens		1 month	No
Secondary	Protective antibody (=1:40) titer after vaccination		1 month	No
Secondary	Influenza-related death		6 months	No