Coronary Artery DiseasePhase 2/3NCT00371098
Influenza Vaccination in Prevention From Acute Coronary Events in Coronary Artery Disease - FLUCAD Study
A Phase 2/3 study testing Influenza vaccination: Influvac (SolvayPharma) in people with Coronary Artery Disease, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
Background: Influenza vaccination is recommended in patients (pts) with cardiovascular disease, however there is a shortage of clinical studies proving its protective effect on clinical course of coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Influenza vaccination: Influvac (SolvayPharma)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 658 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2004to Dec 2005
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, aged 30-80 years, with CAD confirmed by coronarography with at least 50% stenosis of one large epicardial coronary artery.
Who cannot join
- planned cardiovascular surgery within 6 months, congestive heart failure NYHA III/IV, evolving renal failure, neoplastic disease, psycho-organic disorder or any factor impeding follow-up, contraindication to vaccination.
Trial locations and contacts
1 site in 1 country.
Poland1 site
1st Dept. of Coronary Artery Disease, Institute of Cardiology
Warsaw, 04-628
About this study
Official title: Prospective, Randomized, Double-Blind Placebo Controlled Study on Influenza Vaccination in Prevention From Coronary Events in Patients With Coronary Artery Disease Confirmed by Angiography
Background: Influenza vaccination is recommended in patients (pts) with cardiovascular disease, however there is a shortage of clinical studies proving its protective effect on clinical course of coronary artery disease (CAD). The aim of the study was to evaluate the effect of influenza vaccination on the incidence of coronary events in pts with CAD confirmed by coronary angiography.
Read the detailed description
A possible relation between influenza and higher mortality from cardiovascular problems was first noticed in early nineteen hundreds, after epidemics in Europe and United States were discovered (1). In the last decade many studies implicating an important role of inflammation and infection (Herpes virus, Chlamydia pneumoniae, Helicobacter pylori) in development and progression of atherosclerosis (2,3), and markers of inflammation like: hs-CRP, fibrinogen, have become new independent cardiovascular risk factors (4).
Many general physicians now recommend influenza vaccination in patients with coronary artery disease (CAD) despite shortage of studies proving its protective effect on clinical course of CAD. In literature we found only a few reports exploring the hypothesis that influenza vaccination might reduce the incidence of myocardial infarction (MI) and acute coronary syndromes (ACS).
Naghavi et all. in retrospective, case- control study of 218 patients with chronic coronary disease reported that influenza vaccination was strongly associated with freedom from new MI during the same influenza season. (OR 0.33, 95% CI 0.13 to0.82, p=0.017) (5). Gurfinkiel et all. evaluated in prospective, single- blind Fluvacs study that preventive impact of vaccination on subsequent ischemic events at 6 months follow-up. Study group consisted of 301 patients after coronary angioplasty (PCI). The first primary outcome- cardiovascular death occurred in 2% in vaccine group compared with 8% in the control group (p=0.01) and triple composite end point (death, myocardial infarction and hospitalization from ischemia occurred in 11% in vaccine group vs. 23% in controls (p=0.0009) (6). In the contrary, Jackson et all. in largest study of 1378 survivors of first MI, in long (median 2.3 year) follow-up didn't find the benefit of influenza vaccine on the protection against recurrent coronary events (7).
The aim of our study is to evaluate the influence of influenza vaccination on the incidence of cardiac events (cardiovascular death, myocardial infarction, acute coronary syndromes, coronary revascularization and hospitalizations from ischemia) in patients with angiographically confirmed coronary disease.
References:
- Collins SD. Excess mortality from causes other that influenza and pneumonia during influenza epidemics. Public Health Rep. 1932;47:2159-80.
- Sorlie PD, Adam E, Melnick SL, et al. Cytomegalovirus/herpesvirus and carotid atherosclerosis: the ARIC Study. J Med Virol. 1994;42:33-37.
- Zhou YF, Wanishsawad C, Epstein SE. Chlamydia pneumonia-induced transaction of cytomegalovirus: potential synergy of infectious agents in the pathogenesis of atherosclerosis. J Am Coll Cardiol. 1999;33(suppl A):260A.
- Toss H, Lindahl B, Siegbahn A, Wallentin L. (Frisc study group). Prognostic Influence of Increased Fibrinogen and C- reactive Protein Levels in Unstable Coronary Artery Disease. Circulation 1997; 96: 4304- 4210.
- Naghavi M., Barlas Z., Siadaty S., Nagiub S., Madjid M., Casscells W.: Association of influenza vaccination and reduced risk of myocardial infarction Circulation 2000; 102:3039-3045.
- Gurfinkel E.P., Leon de la Fuente R., Mendiz O., Mautner B. For the FLUVACS Study Group: Influenza vaccine pilot study in acute coronary syndromes and planned percutaneous coronary interventions. The FLU vaccination acute coronary syndromes (FLUVACS) Study. Circulation 2002;105:2143-2147.
- Jackson L.A., Heckbert S.R., Psaty B.M., Malais D., Barlow W.E., Thompson W.W. Vaccine Safety Datalink Study Group: Influenza vaccination is not associated with a reduction in the risk of recurrent coronary events. Am. J. Epidemiol. 2002; 156: 634-40.
- Conditions
- Coronary Artery Disease
- Being tested
- Influenza vaccination: Influvac (SolvayPharma), placebo influenza vaccine
- Keywords
- influenza vaccination, coronary artery disease, prevention, acute coronary syndromes
- Medical subject headings
- Coronary Artery Disease, Influenza, Human, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccination: Influvac (SolvayPharma)Biological
placebo influenza vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| active vaccine | Experimental | patients received active influenza vaccine for season 2004/2005 Receives: Biological: Influenza vaccination: Influvac (SolvayPharma) |
| placebo vaccine | Placebo comparator | patients received placebo influenza vaccine for season 2004/2005 containing all vaccine compounds except viral antigens Receives: Biological: placebo influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular death
Measured: 12 months
Secondary outcomes (2)
First composite study end point was Major Adverse Cardiac Event (MACE). MACE was combined of: cardiovascular death, acute myocardial infarction (MI), coronary revascularization (PCI or coronary bypass).
Measured: 12 month
Second composite study end point was Ischemic Event (MACE or hospitalization for ischemia).
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startOct 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Investigators
- Andrzej Ciszewski, MD, PhD, Principal investigator, 1st Dept of Coronary Artery Disease, Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371098
- Sponsor's protocol ID
- IK-NP-0021-2/812/04
- Other IDs
- 2 P05B 016 27
- Status last verified
- Oct 2007
- First submitted
- 31 Aug 2006
- Last updated
- 23 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Ciszewski A, Bilinska ZT, Brydak LB, Kepka C, Kruk M, Romanowska M, Ksiezycka E, Przyluski J, Piotrowski W, Maczynska R, Ruzyllo W. Influenza vaccination in secondary prevention from coronary ischaemic events in coronary artery disease: FLUCAD study. Eur Heart J. 2008 Jun;29(11):1350-8. doi: 10.1093/eurheartj/ehm581. Epub 2008 Jan 10.
PubMed 18187561
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-Blind Placebo Controlled Study on Influenza Vaccination in Prevention From Coronary Events in Patients With Coronary Artery Disease Confirmed by Angiography
- ClinicalTrials.gov ID
- NCT00371098
- Acronym / sponsor ID
- IK-NP-0021-2/812/04
- Conditions
- Coronary Artery Disease
- Keywords
- influenza vaccination, coronary artery disease, prevention, acute coronary syndromes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Oct 2004
- Study completion
- Dec 2005 (actual)
- First posted
- 1 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Influenza vaccination is recommended in patients (pts) with cardiovascular disease, however there is a shortage of clinical studies proving its protective effect on clinical course of coronary artery disease (CAD). The aim of the study was to evaluate the effect of influenza vaccination on the incidence of coronary events in pts with CAD confirmed by coronary angiography.
Detailed description
A possible relation between influenza and higher mortality from cardiovascular problems was first noticed in early nineteen hundreds, after epidemics in Europe and United States were discovered (1). In the last decade many studies implicating an important role of inflammation and infection (Herpes virus, Chlamydia pneumoniae, Helicobacter pylori) in development and progression of atherosclerosis (2,3), and markers of inflammation like: hs-CRP, fibrinogen, have become new independent cardiovascular risk factors (4).
Many general physicians now recommend influenza vaccination in patients with coronary artery disease (CAD) despite shortage of studies proving its protective effect on clinical course of CAD. In literature we found only a few reports exploring the hypothesis that influenza vaccination might reduce the incidence of myocardial infarction (MI) and acute coronary syndromes (ACS).
Naghavi et all. in retrospective, case- control study of 218 patients with chronic coronary disease reported that influenza vaccination was strongly associated with freedom from new MI during the same influenza season. (OR 0.33, 95% CI 0.13 to0.82, p=0.017) (5). Gurfinkiel et all. evaluated in prospective, single- blind Fluvacs study that preventive impact of vaccination on subsequent ischemic events at 6 months follow-up. Study group consisted of 301 patients after coronary angioplasty (PCI). The first primary outcome- cardiovascular death occurred in 2% in vaccine group compared with 8% in the control group (p=0.01) and triple composite end point (death, myocardial infarction and hospitalization from ischemia occurred in 11% in vaccine group vs. 23% in controls (p=0.0009) (6). In the contrary, Jackson et all. in largest study of 1378 survivors of first MI, in long (median 2.3 year) follow-up didn't find the benefit of influenza vaccine on the protection against recurrent coronary events (7).
The aim of our study is to evaluate the influence of influenza vaccination on the incidence of cardiac events (cardiovascular death, myocardial infarction, acute coronary syndromes, coronary revascularization and hospitalizations from ischemia) in patients with angiographically confirmed coronary disease.
References:
- Collins SD. Excess mortality from causes other that influenza and pneumonia during influenza epidemics. Public Health Rep. 1932;47:2159-80.
- Sorlie PD, Adam E, Melnick SL, et al. Cytomegalovirus/herpesvirus and carotid atherosclerosis: the ARIC Study. J Med Virol. 1994;42:33-37.
- Zhou YF, Wanishsawad C, Epstein SE. Chlamydia pneumonia-induced transaction of cytomegalovirus: potential synergy of infectious agents in the pathogenesis of atherosclerosis. J Am Coll Cardiol. 1999;33(suppl A):260A.
- Toss H, Lindahl B, Siegbahn A, Wallentin L. (Frisc study group). Prognostic Influence of Increased Fibrinogen and C- reactive Protein Levels in Unstable Coronary Artery Disease. Circulation 1997; 96: 4304- 4210.
- Naghavi M., Barlas Z., Siadaty S., Nagiub S., Madjid M., Casscells W.: Association of influenza vaccination and reduced risk of myocardial infarction Circulation 2000; 102:3039-3045.
- Gurfinkel E.P., Leon de la Fuente R., Mendiz O., Mautner B. For the FLUVACS Study Group: Influenza vaccine pilot study in acute coronary syndromes and planned percutaneous coronary interventions. The FLU vaccination acute coronary syndromes (FLUVACS) Study. Circulation 2002;105:2143-2147.
- Jackson L.A., Heckbert S.R., Psaty B.M., Malais D., Barlow W.E., Thompson W.W. Vaccine Safety Datalink Study Group: Influenza vaccination is not associated with a reduction in the risk of recurrent coronary events. Am. J. Epidemiol. 2002; 156: 634-40.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active vaccine | Experimental | Biological: Influenza vaccination: Influvac (SolvayPharma)patients received active influenza vaccine for season 2004/2005 |
| placebo vaccine | Placebo comparator | Biological: placebo influenza vaccinepatients received placebo influenza vaccine for season 2004/2005 containing all vaccine compounds except viral antigens |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients, aged 30-80 years, with CAD confirmed by coronarography with at least 50% stenosis of one large epicardial coronary artery.
Key exclusion criteria (1 listed)
- planned cardiovascular surgery within 6 months, congestive heart failure NYHA III/IV, evolving renal failure, neoplastic disease, psycho-organic disorder or any factor impeding follow-up, contraindication to vaccination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccination: Influvac (SolvayPharma) | Biological | active vaccine |
| placebo influenza vaccine | Biological | placebo vaccine |
Primary outcome
cardiovascular death
Time frame: 12 months
2 secondary outcomes
First composite study end point was Major Adverse Cardiac Event (MACE). MACE was combined of: cardiovascular death, acute myocardial infarction (MI), coronary revascularization (PCI or coronary bypass).
Time frame: 12 month
Second composite study end point was Ischemic Event (MACE or hospitalization for ischemia).
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2007.
- Results publication: PubMed 18187561Ciszewski A, Bilinska ZT, Brydak LB, Kepka C, Kruk M, Romanowska M, Ksiezycka E, Przyluski J, Piotrowski W, Maczynska R, Ruzyllo W. Influenza vaccination in secondary prevention from coronary ischaemic events in coronary artery disease: FLUCAD study. Eur Heart J. 2008 Jun;29(11):1350-8. doi: 10.1093/eurheartj/ehm581. Epub 2008 Jan 10.
- Institute of Cardiology, Warsaw, PolandLink provided by the sponsor.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrzej Ciszewski, MD, PhD principal investigator
1st Dept of Coronary Artery Disease, Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Influenza vaccination: Influvac (SolvayPharma) in people with Coronary Artery Disease, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 1 inclusion and 1 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 23 Oct 2007. 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 Poland. 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: 12 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 NCT00371098, which also lists 1 linked publication.
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 23 Oct 2007.