Clinical trial NCT00607217: The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases
Official title: Controlled Trial of Serologic and Clinical Efficacy of Influenza Vaccine in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Diseases
Myocardial Infarction
Stable Angina
Keywords: Coronary artery diseases
Myocardial infarction
Stable angina
Influenza
Vaccine
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 360
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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).

Primary outcomes:
measure: Influenza infection
timeFrame: 6 months
measure: 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]
timeFrame: 1 month
Secondary outcomes:
measure: Magnitude of change in the antibody titer against each of the three influenza vaccine antigens
timeFrame: 1 month
measure: Protective antibody (≥1:40) titer after vaccination
timeFrame: 1 month
measure: Influenza-related death
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shaheed Modarres Medical Center
Study officials:
affiliation: Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran
name: Maryam Keshtkar-Jahromi, M.D.; M.P.H.
role: STUDY_CHAIR
affiliation: Cardiovascular Research Center, Shaheed Beheshti Medical University, Tehran, Iran
name: Hossein Vakili, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran
name: Mohammad Rahnavardi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaheed Beheshti University (MC)
name: Ali Eskandari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaheed Beheshti University (MC)
name: Sharareh Gholamin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaheed Beheshti University (MC)
name: Seyed Mostafa Razavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1001/jama.292.11.1333.
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. doi: 10.1161/CIRCULATIONAHA.106.174516. No abstract available.
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. doi: 10.1161/01.cir.0000016182.85461.f4.
citation: Leon 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. doi: 10.1016/s0300-8932(03)76991-7. Spanish.
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. doi: 10.1093/aje/kwf073.
citation: 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. doi: 10.1016/s0735-1097(00)00804-4.