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

NCT00607178 | Completed Phase 2 DMC

• 2 other identifiers: SBMU- 86-03-105-5433ASMMC- 13861008A
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Diseases; Myocardial Infarction; Stable Angina

Keywords

Influenza; Vaccine

Outcome Measures

Primary Outcomes (1)

• Cardiovascular death

  6 months

Secondary Outcomes (6)

• Acute coronary syndrome (MI or unstable angina)

  6 months

• Admission for Coronary Artery Disease

  6 months

• Angina severity (Seattle Angina Questionnaire [10])

  6 months

• Coronary artery stenosis (modified Gensini score [11])

  6 months

• Coronary revascularization (artery bypass graft or percutaneous coronary intervention)

  6 months

Study Arms (2)

Influenza vaccine

EXPERIMENTAL

Enrolled patients who are randomly assigned to receive influenza vaccine

Biological: influenza vaccine

Placebo

PLACEBO COMPARATOR

Enrolled patients who are randomly assigned to receive placebo of influenza vaccine

Biological: placebo for influenza vaccine

Interventions

influenza vaccine BIOLOGICAL

Intramuscular injection of one 0.5-mL dose of influenza vaccine

Also known as: 2006-2007 vaccination campaign of Influvac (SolvayPharma)

Influenza vaccine

placebo for influenza vaccine BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the diagnosis of acute, evolving or recent MI (after recovered the acute phase) as defined by:
• 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).
• Pathologic findings of an acute MI \[12\]
• Patients with stable angina pectoris and documented coronary artery stenosis (angiography).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Shaheed Modarres Medical Center

Tehran, Tehran Province, 19814, Iran

Location

Related Publications (13)

• Gurfinkel E, Lernoud V. The role of infection and immunity in atherosclerosis. Expert Rev Cardiovasc Ther. 2006 Jan;4(1):131-7. doi: 10.1586/14779072.4.1.131.

  PMID: 16375635 BACKGROUND

• 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. doi: 10.1016/0002-9149(84)90016-x.

  PMID: 6695777 BACKGROUND

• 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. doi: 10.1093/ije/7.3.231.

  PMID: 721358 BACKGROUND

• Gurevich VS. Influenza, autoimmunity and atherogenesis. Autoimmun Rev. 2005 Feb;4(2):101-5. doi: 10.1016/j.autrev.2004.10.006. Epub 2004 Nov 20.

  PMID: 15722256 BACKGROUND

• 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. doi: 10.1161/01.cir.102.25.3039.

  PMID: 11120692 BACKGROUND

• 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.

  PMID: 11994246 BACKGROUND

• 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.

  PMID: 14563288 BACKGROUND

• 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.

  PMID: 12244032 BACKGROUND

• 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. doi: 10.1016/S1473-3099(07)70236-0.

  PMID: 17897608 BACKGROUND

• 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. doi: 10.1016/0735-1097(94)00397-9.

  PMID: 7829785 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 10987628 BACKGROUND

• Dehesh M, Gholamin S, Razavi SM, Eskandari A, Vakili H, Rahnavardi Azari M, Wang Y, Gough EK, Keshtkar-Jahromi M. Influenza Vaccination and Cardiovascular Outcomes in Patients with Coronary Artery Diseases: A Placebo-Controlled Randomized Study, IVCAD. Vaccines (Basel). 2025 Apr 27;13(5):472. doi: 10.3390/vaccines13050472.

  PMID: 40432084 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Angina, Stable; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Maryam Keshtkar-Jahromi, M.D.; M.P.H.

  Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran

  STUDY CHAIR

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: February 5, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 22, 2009

Record last verified: 2008-09

Locations

IR (1)