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AzTrials

Coronary Artery DiseasesPhase 2/3IVCADNCT00607178

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

A Phase 2/3 study testing influenza vaccine in people with Coronary Artery Diseases and Myocardial Infarction, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 25 years and older
What is being tested?
influenza vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
1 siteIran
Study dates
Jan 2008to Sep 2008
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Shaheed Modarres Medical Center

    Tehran, Tehran Province, 19814

Other trials in Iran

About this study

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

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

Read the detailed 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.

Being tested
influenza vaccine, placebo for influenza vaccine
Keywords
Influenza, Vaccine
Medical subject headings
Coronary Artery Disease, Myocardial Infarction, Angina, Stable, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • influenza vaccineBiological

    Also called 2006-2007 vaccination campaign of Influvac (SolvayPharma)

    Intramuscular injection of one 0.5-mL dose of influenza vaccine

  • placebo for influenza vaccineBiological

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

Study groups in NCT00607178
Study groupRoleWhat they receive
Influenza vaccineExperimentalEnrolled patients who are randomly assigned to receive influenza vaccine
Receives: Biological: influenza vaccine
PlaceboPlacebo comparatorEnrolled patients who are randomly assigned to receive placebo of influenza vaccine
Receives: Biological: placebo for influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular death

    Measured: 6 months

Secondary outcomes (6)

  1. Acute coronary syndrome (MI or unstable angina)

    Measured: 6 months

  2. Admission for Coronary Artery Disease

    Measured: 6 months

  3. Angina severity (Seattle Angina Questionnaire [10])

    Measured: 6 months

  4. Coronary artery stenosis (modified Gensini score [11])

    Measured: 6 months

  5. Coronary revascularization (artery bypass graft or percutaneous coronary intervention)

    Measured: 6 months

  6. Influenza infection

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionSep 2008
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00607178
Sponsor's protocol ID
SBMU- 86-03-105-5433A
Other IDs
SMMC- 13861008A
Acronym
IVCAD
Status last verified
Sep 2008
First submitted
10 Jan 2008
Last updated
22 Jan 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16375635

  • 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.

    PubMed 6695777

  • 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.

    PubMed 721358

  • 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.

    PubMed 15722256

  • 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.

    PubMed 11120692

  • 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.

    PubMed 11994246

  • 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.

    PubMed 14563288

  • 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.

    PubMed 12244032

  • 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.

    PubMed 17897608

  • 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.

    PubMed 7829785

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

  • 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.

    PubMed 10987628

  • 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.

    PubMed 40432084

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing influenza vaccine in people with Coronary Artery Diseases and Myocardial Infarction, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular death (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00607178, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2009.

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