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Coronary Artery DiseasesPhase 2/3NCT00607217

The Efficacy of Influenza Vaccination 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

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. Read more about this study

Who is it for?
Ages 25 years and olderHealthy volunteers can take part
What is being tested?
influenza vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
360 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

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
Show all 9Show fewer
  • 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

Other trials in Iran

About this study

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

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.
Read the 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).

Being tested
influenza vaccine, placebo for influenza vaccine
Keywords
Coronary artery diseases, Myocardial infarction, Stable angina, 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

  • influenza vaccineBiological

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

    Intramuscular injection of one 0.5-mL dose of influenza vaccine

Study groups in NCT00607217
Study groupRoleWhat they receive
CAD-ExpExperimentalEnrolled coronary artery disease patients who are randomly assigned to receive influenza vaccine
Receives: Biological: influenza vaccine
CAD-ControlPlacebo comparatorEnrolled coronary artery disease patients who are randomly assigned to receive placebo of influenza vaccine
Receives: Biological: placebo for influenza vaccine
Healthy-ControlExperimentalEnrolled healthy subjects serve as control for CAD-Exp
Receives: Biological: influenza vaccine

What is being measured

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

  1. Influenza infection

    Measured: 6 months

  2. 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]

    Measured: 1 month

Secondary outcomes (3)

  1. Magnitude of change in the antibody titer against each of the three influenza vaccine antigens

    Measured: 1 month

  2. Protective antibody (≥1:40) titer after vaccination

    Measured: 1 month

  3. Influenza-related death

    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
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00607217
Sponsor's protocol ID
SBMU- 86-03-105-5433B
Other IDs
SMMC- 13861008B
Status last verified
Sep 2008
First submitted
10 Jan 2008
Last updated
22 Jan 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15367555

  • 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.

    PubMed 16702489

  • 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

  • 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

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 9 inclusion and 9 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?

Influenza infection (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT00607217, which also lists 6 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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